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Effectiveness of Ultrafiltration in Treating People With Acute Decompensated Heart Failure and Cardiorenal Syndrome (The CARRESS Study) (CARRESS)

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ClinicalTrials.gov Identifier: NCT00608491
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
CHF Solutions
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Interventions Drug: Stepped pharmacologic care
Device: Ultrafiltration
Enrollment 188
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes Participants will receive ultrafiltration
Period Title: Overall Study
Started 94 94
Completed 73 72
Not Completed 21 22
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration Total
Hide Arm/Group Description Participants will receive stepped pharmacologic care Participants will receive ultrafiltration Total of all reporting groups
Overall Number of Baseline Participants 94 94 188
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 94 participants 188 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
  44.7%
35
  37.2%
77
  41.0%
>=65 years
52
  55.3%
59
  62.8%
111
  59.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 94 participants 188 participants
67.1  (13.7) 68.9  (12.0) 68.0  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 94 participants 188 participants
Female
26
  27.7%
21
  22.3%
47
  25.0%
Male
68
  72.3%
73
  77.7%
141
  75.0%
1.Primary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.04  (0.53) 0.23  (0.70)
2.Primary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: lbs
-12.1  (11.3) -12.6  (8.5)
3.Secondary Outcome
Title Change in Glomerular Filtration Rate
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mL/min
1.67  (10.94) 0.93  (14.60)
4.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.00  (0.60) 0.11  (0.89)
5.Secondary Outcome
Title Change in Glomerular Filtration Rate
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mL/min
2.06  (9.32) 1.82  (13.84)
6.Secondary Outcome
Title Changes in Weight
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 90 88
Mean (Standard Deviation)
Unit of Measure: lbs
-3.4  (5.2) -4.4  (4.5)
7.Secondary Outcome
Title Changes in Weight
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 91
Mean (Standard Deviation)
Unit of Measure: lbs
-7.4  (8.6) -8.8  (7.4)
8.Secondary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 88 86
Mean (Standard Deviation)
Unit of Measure: lbs
-10.8  (10.5) -11.7  (7.7)
9.Secondary Outcome
Title Changes in Weight
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 62 69
Mean (Standard Deviation)
Unit of Measure: lbs
-15.6  (12.0) -14.3  (10.0)
10.Secondary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame Change from Baseline to Day 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 51 59
Mean (Standard Deviation)
Unit of Measure: lbs
-16.5  (15.3) -15.7  (11.8)
11.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: mL
1714.1  (1400.2) 2193.6  (1554.9)
12.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 92 93
Mean (Standard Deviation)
Unit of Measure: mL
3814.2  (2384.2) 4705.8  (2626.9)
13.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 89 90
Mean (Standard Deviation)
Unit of Measure: mL
5706.8  (3490.6) 6257.1  (3519.7)
14.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 79 81
Mean (Standard Deviation)
Unit of Measure: mL
7081.5  (4183.4) 7443.0  (4328.7)
15.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 63 69
Mean (Standard Deviation)
Unit of Measure: mL
8358.8  (5034.5) 8308.4  (5178.1)
16.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 53 55
Mean (Standard Deviation)
Unit of Measure: mL
9700.7  (6945.9) 9822.1  (6001.7)
17.Secondary Outcome
Title Cumulative Net Fluid Loss
Hide Description [Not Specified]
Time Frame Randomization through Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 40 47
Mean (Standard Deviation)
Unit of Measure: mL
11659.6  (9142.0) 10595.1  (7097.4)
18.Secondary Outcome
Title Dyspnea Visual Analog Scale
Hide Description

Scale range: -100 , +100

-100=worse, +100=better

Time Frame Change from Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 88 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.5  (27.8) 16.5  (29.2)
19.Secondary Outcome
Title Change in Global Visual Analog Scale
Hide Description

Scale range: -100 , +100

-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”.

Time Frame Change from Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 87 81
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.8  (25.8) 13.7  (27.9)
20.Secondary Outcome
Title Change in Dyspnea Visual Analog Scale
Hide Description

Scale range: -100 , +100

-100=worse, +100=better

Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 88 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.8  (27.6) 19.4  (31.4)
21.Secondary Outcome
Title Change in Global Visual Analog Scale
Hide Description

Scale range: -100 , +100

-100=worse, +100=better Participants asked to mark their global well being on a 10 cm vertical line, with the top labeled “best you have ever felt” and the bottom labeled “worst you have ever felt”.

Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 87 86
Mean (Standard Deviation)
Unit of Measure: units on a scale
25.8  (30.2) 16.9  (29.0)
22.Secondary Outcome
Title Change in Furosemide-Equivalent Dose
Hide Description Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 92 89
Mean (Standard Deviation)
Unit of Measure: mg
2.2  (166.5) -20.6  (116.0)
23.Secondary Outcome
Title Change in Blood Sodium Level
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mEq/L
0.00  (3.60) -2.3  (3.51)
24.Secondary Outcome
Title Change in Blood Potassium Level
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mEq/L
-0.23  (0.63) 0.26  (0.70)
25.Secondary Outcome
Title Change in Blood Urea Nitrogen/Urea
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.68  (18.29) 12.54  (24.81)
26.Secondary Outcome
Title Change in Blood Bicarbonate Level
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: mEq/L
3.29  (3.82) -1.01  (4.17)
27.Secondary Outcome
Title Change in Blood Hemoglobin Level
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 89 93
Mean (Standard Deviation)
Unit of Measure: g/dL
0.38  (0.76) -0.01  (0.92)
28.Secondary Outcome
Title Change in Blood Sodium Level
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mEq/L
-0.49  (3.70) -2.02  (4.11)
29.Secondary Outcome
Title Change in Blood Potassium Level
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 92
Mean (Standard Deviation)
Unit of Measure: mEq/L
-0.14  (0.60) 0.27  (0.75)
30.Secondary Outcome
Title Change in Blood Urea Nitrogen/Urea
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: mg/dL
7.23  (20.69) 13.81  (23.91)
31.Secondary Outcome
Title Change in Blood Bicarbonate Level
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: mEq/L
3.07  (4.50) -0.70  (5.03)
32.Secondary Outcome
Title Change in Blood Hemoglobin Level
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 89 93
Mean (Standard Deviation)
Unit of Measure: g/dL
0.35  (0.94) -0.02  (0.96)
33.Secondary Outcome
Title Change in Blood Cystatin C
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 85 81
Mean (Standard Deviation)
Unit of Measure: mg/L
0.14  (0.52) 0.22  (0.52)
34.Secondary Outcome
Title Change in Uric Acid
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 85 80
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.06  (1.44) -0.23  (1.67)
35.Secondary Outcome
Title Change in Blood N- Terminal Pro- BNP
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 84 79
Mean (Standard Deviation)
Unit of Measure: pg/mL
-978.61  (2902.06) -814.45  (9238.91)
36.Secondary Outcome
Title Change in Plasma Renin Activity
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 85 81
Mean (Standard Deviation)
Unit of Measure: ng/mL/hr
5.78  (45.65) 12.67  (31.32)
37.Secondary Outcome
Title Change in Blood High Sensitivity Troponin I
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 84 81
Mean (Standard Deviation)
Unit of Measure: pg/mL
47.38  (369.85) -38.95  (1027.37)
38.Secondary Outcome
Title Change in Blood Aldosterone
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 81
Mean (Standard Deviation)
Unit of Measure: pg/mL
-109.13  (489.50) -3.07  (485.40)
39.Secondary Outcome
Title Change in Blood Procollagen III N-terminal Propepide
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 81
Mean (Standard Deviation)
Unit of Measure: ug/L
0.22  (4.69) -0.64  (4.02)
40.Secondary Outcome
Title Change in Blood Endothelin-1
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 83 78
Mean (Standard Deviation)
Unit of Measure: pg/mL
-0.76  (1.70) -1.13  (3.20)
41.Secondary Outcome
Title Change in Blood High Sensitivity C-Reactive Protein
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 85 81
Mean (Standard Deviation)
Unit of Measure: mg/L
-1.71  (46.14) 1.89  (28.60)
42.Secondary Outcome
Title Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
Hide Description [Not Specified]
Time Frame Baseline to Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 83 76
Mean (Standard Deviation)
Unit of Measure: ug/L
7.63  (11.93) 9.07  (13.46)
43.Secondary Outcome
Title Change in Blood Cystatin C
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 83
Mean (Standard Deviation)
Unit of Measure: mg/L
0.12  (0.48) 0.09  (0.66)
44.Secondary Outcome
Title Change in Blood Uric Acid
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.10  (1.85) -0.15  (2.07)
45.Secondary Outcome
Title Change in Blood N Terminal Pro-Natriuretic Peptide
Hide Description [Not Specified]
Time Frame Baseline to Day 7/Discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 83
Mean (Standard Deviation)
Unit of Measure: pg/mL
-1071.88  (3309.45) -740.82  (8604.86)
46.Secondary Outcome
Title Change in Plasma Renin Activity
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 83
Mean (Standard Deviation)
Unit of Measure: ng/mL/hr
2.58  (40.70) 11.40  (32.75)
47.Secondary Outcome
Title Change in Blood High Sensitivity Troponin I
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 83
Mean (Standard Deviation)
Unit of Measure: pg/mL
37.28  (350.45) -37.16  (1231.12)
48.Secondary Outcome
Title Change in Blood Aldosterone
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 87 83
Mean (Standard Deviation)
Unit of Measure: pg/mL
-74.26  (507.96) 68.13  (624.35)
49.Secondary Outcome
Title Change in Blood Procollagen III N-terminal Propepide
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 87 83
Mean (Standard Deviation)
Unit of Measure: ug/L
-0.07  (5.90) -0.93  (3.54)
50.Secondary Outcome
Title Change in Blood Endothelin-1
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 85 83
Mean (Standard Deviation)
Unit of Measure: pg/mL
-0.69  (1.85) -1.24  (3.22)
51.Secondary Outcome
Title Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 85 83
Mean (Standard Deviation)
Unit of Measure: ug/L
10.21  (15.79) 10.54  (15.04)
52.Secondary Outcome
Title Change in Blood High Sensitivity C-Reactive Protein
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Time Frame Baseline to Day 7/Discharge
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 86 83
Mean (Standard Deviation)
Unit of Measure: mg/L
-6.39  (48.56) 2.18  (37.72)
53.Secondary Outcome
Title Weight Change
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Time Frame Baseline to Day 30
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 73 68
Mean (Standard Deviation)
Unit of Measure: lbs
-15.9  (22.4) -13.4  (21.0)
54.Secondary Outcome
Title Change in Furosemide-Equivalent Dose
Hide Description Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Time Frame Baseline to Day 30
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
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Overall Number of Participants Analyzed 78 74
Mean (Standard Deviation)
Unit of Measure: mg
9.8  (188.3) 27.3  (120.1)
55.Secondary Outcome
Title Creatinine Change
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Time Frame Baseline to Day 30
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 75 70
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.25  (0.68) -0.12  (0.59)
56.Secondary Outcome
Title Glomerular Filtration Rate Change
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Time Frame Baseline to Day 30
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 75 70
Mean (Standard Deviation)
Unit of Measure: mL/min
7.95  (11.85) 6.07  (16.13)
57.Secondary Outcome
Title Weight Change
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 66 63
Mean (Standard Deviation)
Unit of Measure: lbs
-17.2  (21.1) -15.4  (23.1)
58.Secondary Outcome
Title Change in Furosemide-Equivalent Dose
Hide Description Furosemide-Equivalent Dose is the dose bumetanide or torsemide converted to furosemide equivalent (Torsemide dose x 2,Bumetanide dose x 40)
Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 73 72
Mean (Standard Deviation)
Unit of Measure: mg
-12.4  (122.5) 8.8  (128.5)
59.Secondary Outcome
Title Best Available Serum Creatinine Change
Hide Description Core laboratory when available. If not available, local laboratory results were used.
Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 67 70
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.28  (0.61) -0.12  (0.67)
60.Secondary Outcome
Title Best Available Glomerular Filtration Rate Change
Hide Description Core laboratory when available. If not available, local laboratory results were used.
Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 67 70
Mean (Standard Deviation)
Unit of Measure: mL/min
8.86  (13.26) 5.63  (16.49)
61.Secondary Outcome
Title Change in Blood Uric Acid
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 54
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.31  (2.28) -0.54  (2.60)
62.Secondary Outcome
Title Change in Blood Cystatin C
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: mg/L
-0.18  (0.48) -0.03  (0.60)
63.Secondary Outcome
Title Change in Blood N Terminal Pro - B Natriuretic Peptides
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: pg/mL
-490.56  (5638.86) -937.69  (7389.14)
64.Secondary Outcome
Title Change in Plasma Renin Activity
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: ng/mL/hr
-2.18  (41.12) 0.54  (20.48)
65.Secondary Outcome
Title Change in Blood High Sensitivity Troponin I
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: pg/mL
-17.48  (106.70) -73.58  (511.98)
66.Secondary Outcome
Title Change in Blood Aldosterone
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 57 55
Mean (Standard Deviation)
Unit of Measure: pg/mL
-6.91  (672.21) 40.35  (471.50)
67.Secondary Outcome
Title Change in Blood Procollagen III N-terminal Propepide
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 57 56
Mean (Standard Deviation)
Unit of Measure: ug/L
0.75  (5.25) 0.58  (6.02)
68.Secondary Outcome
Title Change in Blood Endothelin-1
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Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: pg/mL
-0.82  (1.58) -1.32  (3.98)
69.Secondary Outcome
Title Change in Blood High Sensitivity C-Reactive Protein
Hide Description [Not Specified]
Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description:
Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: mg/L
-13.62  (59.58) 1.99  (44.92)
70.Secondary Outcome
Title Change in Blood Carboxy-terminal Telopeptide of Collagen Type I
Hide Description [Not Specified]
Time Frame Baseline to Day 60
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Participants analyzed consisted of those participants who had the endpoint data available to be derived.
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
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Participants will receive stepped pharmacologic care
Participants will receive ultrafiltration
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: ug/L
2.24  (13.44) 4.57  (27.84)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stepped Pharmacologic Care Ultrafiltration
Hide Arm/Group Description Participants will receive stepped pharmacologic care Participants will receive ultrafiltration
All-Cause Mortality
Stepped Pharmacologic Care Ultrafiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stepped Pharmacologic Care Ultrafiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   54/94 (57.45%)   68/94 (72.34%) 
Blood and lymphatic system disorders     
Anaemia  5/94 (5.32%)  6/94 (6.38%) 
Heparin-Induced Thrombocytopenia  0/94 (0.00%)  1/94 (1.06%) 
Thrombocytopenia  0/94 (0.00%)  1/94 (1.06%) 
Cardiac disorders     
Acute Coronary Syndrome  0/94 (0.00%)  1/94 (1.06%) 
Acute Myocardial Infarction  0/94 (0.00%)  1/94 (1.06%) 
Angina Pectoris  1/94 (1.06%)  1/94 (1.06%) 
Atrial Fibrillation  1/94 (1.06%)  2/94 (2.13%) 
Cardiac Failure  17/94 (18.09%)  16/94 (17.02%) 
Cardiac Failure Acute  12/94 (12.77%)  15/94 (15.96%) 
Cardiac Failure Chronic  0/94 (0.00%)  2/94 (2.13%) 
Pulseless Electrical Activity  1/94 (1.06%)  0/94 (0.00%) 
Sinus Tachycardia  0/94 (0.00%)  1/94 (1.06%) 
Ventricular Fibrillation  1/94 (1.06%)  0/94 (0.00%) 
Ventricular Tachycardia  1/94 (1.06%)  0/94 (0.00%) 
Renal and urinary disorders     
Haematuria  1/94 (1.06%)  2/94 (2.13%) 
Renal Failure  11/94 (11.70%)  10/94 (10.64%) 
Renal Failure Acute  3/94 (3.19%)  6/94 (6.38%) 
Renal Failure Chronic  2/94 (2.13%)  0/94 (0.00%) 
Renal Impairment  0/94 (0.00%)  1/94 (1.06%) 
Renal Tubular Necrosis  0/94 (0.00%)  1/94 (1.06%) 
Urinary Tract Obstruction  0/94 (0.00%)  1/94 (1.06%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stepped Pharmacologic Care Ultrafiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/94 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jenny Ibarra
Organization: Duke University
Phone: 9192363291
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00608491     History of Changes
Other Study ID Numbers: Pro00018064
U01HL084904-04 ( U.S. NIH Grant/Contract )
U01HL084904 ( U.S. NIH Grant/Contract )
522
First Submitted: January 25, 2008
First Posted: February 6, 2008
Results First Submitted: February 18, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013