ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stepped Pharmacologic Care Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
Ultrafiltration Participants will receive ultrafiltration

Participant Flow:   Overall Study
    Stepped Pharmacologic Care   Ultrafiltration
STARTED   94   94 
COMPLETED   73   72 
NOT COMPLETED   21   22 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stepped Pharmacologic Care Participants will receive stepped pharmacologic care
Ultrafiltration Participants will receive ultrafiltration
Total Total of all reporting groups

Baseline Measures
   Stepped Pharmacologic Care   Ultrafiltration   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   94   188 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   42   35   77 
>=65 years   52   59   111 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.1  (13.7)   68.9  (12.0)   68.0  (12.9) 
Gender 
[Units: Participants]
     
Female   26   21   47 
Male   68   73   141 


  Outcome Measures

1.  Primary:   Change in Serum Creatinine   [ Time Frame: Change from Baseline to Day 4 ]

2.  Primary:   Change in Weight   [ Time Frame: Change from Baseline to Day 4 ]

3.  Secondary:   Change in Glomerular Filtration Rate   [ Time Frame: Change from Baseline to Day 4 ]

4.  Secondary:   Change in Serum Creatinine   [ Time Frame: Change from Baseline to Day 7 ]

5.  Secondary:   Change in Glomerular Filtration Rate   [ Time Frame: Change from Baseline to Day 7 ]

6.  Secondary:   Changes in Weight   [ Time Frame: Change from Baseline to Day 1 ]

7.  Secondary:   Changes in Weight   [ Time Frame: Change from Baseline to Day 2 ]

8.  Secondary:   Change in Weight   [ Time Frame: Change from Baseline to Day 3 ]

9.  Secondary:   Changes in Weight   [ Time Frame: Change from Baseline to Day 5 ]

10.  Secondary:   Change in Weight   [ Time Frame: Change from Baseline to Day 6 ]

11.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 1 ]

12.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 2 ]

13.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 3 ]

14.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 4 ]

15.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 5 ]

16.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 6 ]

17.  Secondary:   Cumulative Net Fluid Loss   [ Time Frame: Randomization through Day 7 ]

18.  Secondary:   Dyspnea Visual Analog Scale   [ Time Frame: Change from Baseline to Day 4 ]

19.  Secondary:   Change in Global Visual Analog Scale   [ Time Frame: Change from Baseline to Day 4 ]

20.  Secondary:   Change in Dyspnea Visual Analog Scale   [ Time Frame: Baseline to Day 7/Discharge ]

21.  Secondary:   Change in Global Visual Analog Scale   [ Time Frame: Baseline to Day 7/Discharge ]

22.  Secondary:   Change in Furosemide-Equivalent Dose   [ Time Frame: Baseline to Day 7/Discharge ]

23.  Secondary:   Change in Blood Sodium Level   [ Time Frame: Baseline to Day 4 ]

24.  Secondary:   Change in Blood Potassium Level   [ Time Frame: Baseline to Day 4 ]

25.  Secondary:   Change in Blood Urea Nitrogen/Urea   [ Time Frame: Baseline to Day 4 ]

26.  Secondary:   Change in Blood Bicarbonate Level   [ Time Frame: Baseline to Day 4 ]

27.  Secondary:   Change in Blood Hemoglobin Level   [ Time Frame: Baseline to Day 4 ]

28.  Secondary:   Change in Blood Sodium Level   [ Time Frame: Baseline to Day 7/Discharge ]

29.  Secondary:   Change in Blood Potassium Level   [ Time Frame: Baseline to Day 7/Discharge ]

30.  Secondary:   Change in Blood Urea Nitrogen/Urea   [ Time Frame: Baseline to Day 7/Discharge ]

31.  Secondary:   Change in Blood Bicarbonate Level   [ Time Frame: Baseline to Day 7/Discharge ]

32.  Secondary:   Change in Blood Hemoglobin Level   [ Time Frame: Baseline to Day 7/Discharge ]

33.  Secondary:   Change in Blood Cystatin C   [ Time Frame: Baseline to Day 4 ]

34.  Secondary:   Change in Uric Acid   [ Time Frame: Baseline to Day 4 ]

35.  Secondary:   Change in Blood N- Terminal Pro- BNP   [ Time Frame: Baseline to Day 4 ]

36.  Secondary:   Change in Plasma Renin Activity   [ Time Frame: Baseline to Day 4 ]

37.  Secondary:   Change in Blood High Sensitivity Troponin I   [ Time Frame: Baseline to Day 4 ]

38.  Secondary:   Change in Blood Aldosterone   [ Time Frame: Baseline to Day 4 ]

39.  Secondary:   Change in Blood Procollagen III N-terminal Propepide   [ Time Frame: Baseline to Day 4 ]

40.  Secondary:   Change in Blood Endothelin-1   [ Time Frame: Baseline to Day 4 ]

41.  Secondary:   Change in Blood High Sensitivity C-Reactive Protein   [ Time Frame: Baseline to Day 4 ]

42.  Secondary:   Change in Blood Carboxy-terminal Telopeptide of Collagen Type I   [ Time Frame: Baseline to Day 4 ]

43.  Secondary:   Change in Blood Cystatin C   [ Time Frame: Baseline to Day 7/Discharge ]

44.  Secondary:   Change in Blood Uric Acid   [ Time Frame: Baseline to Day 7/Discharge ]

45.  Secondary:   Change in Blood N Terminal Pro-Natriuretic Peptide   [ Time Frame: Baseline to Day 7/Discharge ]

46.  Secondary:   Change in Plasma Renin Activity   [ Time Frame: Baseline to Day 7/Discharge ]

47.  Secondary:   Change in Blood High Sensitivity Troponin I   [ Time Frame: Baseline to Day 7/Discharge ]

48.  Secondary:   Change in Blood Aldosterone   [ Time Frame: Baseline to Day 7/Discharge ]

49.  Secondary:   Change in Blood Procollagen III N-terminal Propepide   [ Time Frame: Baseline to Day 7/Discharge ]

50.  Secondary:   Change in Blood Endothelin-1   [ Time Frame: Baseline to Day 7/Discharge ]

51.  Secondary:   Change in Blood Carboxy-terminal Telopeptide of Collagen Type I   [ Time Frame: Baseline to Day 7/Discharge ]

52.  Secondary:   Change in Blood High Sensitivity C-Reactive Protein   [ Time Frame: Baseline to Day 7/Discharge ]

53.  Secondary:   Weight Change   [ Time Frame: Baseline to Day 30 ]

54.  Secondary:   Change in Furosemide-Equivalent Dose   [ Time Frame: Baseline to Day 30 ]

55.  Secondary:   Creatinine Change   [ Time Frame: Baseline to Day 30 ]

56.  Secondary:   Glomerular Filtration Rate Change   [ Time Frame: Baseline to Day 30 ]

57.  Secondary:   Weight Change   [ Time Frame: Baseline to Day 60 ]

58.  Secondary:   Change in Furosemide-Equivalent Dose   [ Time Frame: Baseline to Day 60 ]

59.  Secondary:   Best Available Serum Creatinine Change   [ Time Frame: Baseline to Day 60 ]

60.  Secondary:   Best Available Glomerular Filtration Rate Change   [ Time Frame: Baseline to Day 60 ]

61.  Secondary:   Change in Blood Uric Acid   [ Time Frame: Baseline to Day 60 ]

62.  Secondary:   Change in Blood Cystatin C   [ Time Frame: Baseline to Day 60 ]

63.  Secondary:   Change in Blood N Terminal Pro - B Natriuretic Peptides   [ Time Frame: Baseline to Day 60 ]

64.  Secondary:   Change in Plasma Renin Activity   [ Time Frame: Baseline to Day 60 ]

65.  Secondary:   Change in Blood High Sensitivity Troponin I   [ Time Frame: Baseline to Day 60 ]

66.  Secondary:   Change in Blood Aldosterone   [ Time Frame: Baseline to Day 60 ]

67.  Secondary:   Change in Blood Procollagen III N-terminal Propepide   [ Time Frame: Baseline to Day 60 ]

68.  Secondary:   Change in Blood Endothelin-1   [ Time Frame: Baseline to Day 60 ]

69.  Secondary:   Change in Blood High Sensitivity C-Reactive Protein   [ Time Frame: Baseline to Day 60 ]

70.  Secondary:   Change in Blood Carboxy-terminal Telopeptide of Collagen Type I   [ Time Frame: Baseline to Day 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jenny.ibarra@duke.edu


Publications of Results:
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