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Trial record 3 of 4 for:    21366472 [PUBMED-IDS]

Determining Optimal Dose and Duration of Diuretic Treatment in People With Acute Heart Failure (The DOSE-AHF Study)

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: NCT00577135
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : May 27, 2013
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Heart Failure
Interventions Drug: Furosemide-Q12 hour bolus
Drug: Furosemide-Continuous Infusion
Drug: Furosemide-Low Intensification
Drug: Furosemide-High Intensification
Enrollment 308

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Q12 Hours Bolus & Low Intensification Q12 Hours Bolus & High Intensification Continuous Infusion & Low Intensification Continuous Infusion & High Intensification
Hide Arm/Group Description Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus Low intensification (1 x oral dose) IV furosemide by continuous infusion High intensification (2.5 x oral dose) IV furosemide by continuous infusion
Period Title: Overall Study
Started 74 82 77 75
Completed 74 82 77 75
Not Completed 0 0 0 0
Arm/Group Title Q12 Hours Bolus & Low Intensification Q12 Hours Bolus & High Intensification Continuous Infusion & Low Intensification Continuous Infusion & High Intensification Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 74 82 77 75 308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 82 participants 77 participants 75 participants 308 participants
67.4  (12.4) 65.2  (13.8) 64.5  (14.1) 67.2  (14.0) 66.0  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 82 participants 77 participants 75 participants 308 participants
Female
18
  24.3%
23
  28.0%
23
  29.9%
18
  24.0%
82
  26.6%
Male
56
  75.7%
59
  72.0%
54
  70.1%
57
  76.0%
226
  73.4%
1.Primary Outcome
Title Patient Well Being, as Determined by a Visual Analog Scale
Hide Description Global Visual Analog Scale Scale Range 0-7200; higher score is better
Time Frame Measured at 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 154 149 148 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
4236  (1440.4) 4372.7  (1404.4) 4170.8  (1436.3) 4429.6  (1401.4)
2.Primary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame Measured at baseline and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 155 146 147 154
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.05  (0.30) 0.07  (0.30) 0.04  (0.29) 0.08  (0.31)
3.Secondary Outcome
Title Change in Weight
Hide Description [Not Specified]
Time Frame baseline and 96 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 151 142 141 152
Mean (Standard Deviation)
Unit of Measure: lbs
-8.0  (7.8) -9.1  (10.2) -7.4  (10.1) -9.6  (7.9)
4.Secondary Outcome
Title Proportion of Patients Free of Congestion
Hide Description [Not Specified]
Time Frame Measured at 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 153 144 143 154
Measure Type: Number
Unit of Measure: percentage of participants
14.4 15.3 11.2 18.2
5.Secondary Outcome
Title Dyspnea, as Determined by Visual Analog Scales
Hide Description Global Visual Analog Scale Scale Range 0-2400; higher score is better
Time Frame Measured at 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 153 149 147 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
1370.8  (486.0) 1453.8  (518.0) 1426.0  (504.5) 1398.2  (502.7)
6.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame baseline and 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 154 146 147 153
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.00  (0.18) 0.01  (0.17) -0.01  (0.16) 0.02  (0.19)
7.Secondary Outcome
Title Change in Cystatin C
Hide Description [Not Specified]
Time Frame baseline and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 125 122 121 126
Mean (Standard Deviation)
Unit of Measure: mg/L
0.11  (0.30) 0.17  (0.35) 0.12  (0.35) 0.17  (0.31)
8.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame baseline and 48 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 155 146 147 154
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.02  (0.23) 0.05  (0.26) 0.01  (0.23) 0.06  (0.25)
9.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame baseline and 96 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 155 146 147 154
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.06  (0.32) 0.05  (0.32) 0.05  (0.33) 0.07  (0.31)
10.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame baseline and day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 155 146 147 154
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.10  (0.40) 0.04  (0.32) 0.07  (0.33) 0.08  (0.40)
11.Secondary Outcome
Title Change in Serum Creatinine
Hide Description [Not Specified]
Time Frame baseline and day 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 117 116 114 119
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.09  (0.41) 0.07  (0.45) 0.09  (0.43) 0.07  (0.43)
12.Secondary Outcome
Title Patient Well Being, as Determined by a Visual Analog Scale
Hide Description Global Visual Analog Scale Scale Range 0-2400; higher score is better
Time Frame Measured at 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 153 149 147 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
1280.8  (469.7) 1303.0  (465.1) 1288.6  (455.9) 1294.8  (478.4)
13.Secondary Outcome
Title Patient Well Being, as Determined by a Visual Analog Scale
Hide Description Global Visual Analog Scale Scale Range 0-4800; higher score is better
Time Frame 48 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 153 149 147 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
2722.6  (940.0) 2792.6  (932.7) 2706.5  (931.5) 2805.2  (939.8)
14.Secondary Outcome
Title Dyspnea VAS
Hide Description Dyspnea Visual Analog Scale Scale Range 0-4800; higher score is better
Time Frame 48 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 153 149 147 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
2876.6  (960.1) 3033.1  (1039.3) 2924.9  (1012.8) 2981.3  (992.9)
15.Secondary Outcome
Title Dyspnea VAS
Hide Description Dyspnea Visual Analog Scale Scale Range 0-7200; higher score is better
Time Frame 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 154 149 148 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
4455.6  (1468.4) 4699.1  (1572.7) 4477.9  (1549.7) 4668.3  (1496.0)
16.Secondary Outcome
Title Change in Cystatin C
Hide Description [Not Specified]
Time Frame baseline and day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 137 131 131 137
Mean (Standard Deviation)
Unit of Measure: mg/L
0.21  (0.43) 0.16  (0.48) 0.16  (0.48) 0.21  (0.42)
17.Secondary Outcome
Title Change in Cystatin C
Hide Description [Not Specified]
Time Frame baseline and day 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 92 98 91 99
Mean (Standard Deviation)
Unit of Measure: mg/L
0.20  (0.51) 0.16  (0.43) 0.18  (0.47) 0.18  (0.46)
18.Secondary Outcome
Title Change in Uric Acid
Hide Description [Not Specified]
Time Frame baseline and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 125 121 120 126
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.30  (1.02) 0.44  (1.20) 0.11  (1.01) 0.61  (1.15)
19.Secondary Outcome
Title Change in Uric Acid
Hide Description [Not Specified]
Time Frame baseline and day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 137 130 130 137
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.40  (1.47) 0.09  (1.96) 0.07  (1.69) 0.42  (1.75)
20.Secondary Outcome
Title Change in Uric Acid
Hide Description [Not Specified]
Time Frame baseline and Day 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 92 99 93 98
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.09  (2.28) -0.71  (2.27) -0.13  (2.33) -0.67  (2.24)
21.Secondary Outcome
Title Change in B-type Natriuretic Peptide
Hide Description Change in NTproBNP
Time Frame baseline and 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 124 121 121 124
Mean (Standard Deviation)
Unit of Measure: pg/mL
-1316.2  (4364.3) -1773.2  (3827.5) -1193.8  (4094.1) -1881.6  (4105.4)
22.Secondary Outcome
Title Change in NTproBNP
Hide Description [Not Specified]
Time Frame baseline and Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 136 130 131 135
Mean (Standard Deviation)
Unit of Measure: pg/mL
-1133.3  (4883.4) -1552.0  (4875.8) -1037.2  (5211.8) -1629.7  (4524.6)
23.Secondary Outcome
Title Change in NTproBNP
Hide Description [Not Specified]
Time Frame baseline and Day 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 91 98 91 98
Mean (Standard Deviation)
Unit of Measure: pg/mL
-1449.3  (5010.1) -1035.1  (6962.9) -1445.6  (5805.3) -1038.5  (6364.3)
24.Secondary Outcome
Title Presence of Cardiorenal Syndrome
Hide Description [Not Specified]
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 155 146 147 154
Measure Type: Number
Unit of Measure: percentage of participants
17.4 19.2 13.6 22.7
25.Secondary Outcome
Title Treatment Failure
Hide Description Treatment failure is defined as the patient met cardiorenal syndrome endpoint, worsening or persistent heart failure endpoint, patient died, or there was clinical evidence of overdiuresis requiring intervention within first 72 hours after randomization
Time Frame Within 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 155 147 147 155
Measure Type: Number
Unit of Measure: percentage of participants
38.1 38.8 36.7 40.0
26.Secondary Outcome
Title Net Fluid Loss
Hide Description [Not Specified]
Time Frame Through 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 150 140 141 149
Mean (Standard Deviation)
Unit of Measure: mL
1595.7  (1476.7) 1796.4  (1685.1) 1209.7  (1309.3) 2149.6  (1681.7)
27.Secondary Outcome
Title Net Fluid Loss
Hide Description [Not Specified]
Time Frame Through 48 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 148 136 139 145
Mean (Standard Deviation)
Unit of Measure: mL
2996.7  (2490.5) 3120.6  (2504.2) 2334.8  (2006.4) 3747.4  (2716.1)
28.Secondary Outcome
Title Net Fluid Loss
Hide Description [Not Specified]
Time Frame Through 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Each analysis performed for this trial was done twice. The first analysis compared Q12hour versus continuous, the second analysis compared low intensification versus high intensification. The study was not testing the combined 4 way as a pre-specified analysis.
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 129 113 120 122
Mean (Standard Deviation)
Unit of Measure: mL
4236.7  (3207.6) 4249.2  (3104.3) 3575.2  (2634.8) 4898.9  (3478.5)
Time Frame [Not Specified]
Adverse Event Reporting Description Only Serious Adverse Events were collected for this study
 
Arm/Group Title Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   69/156 (44.23%)   67/152 (44.08%)   76/151 (50.33%)   60/157 (38.22%) 
Blood and lymphatic system disorders         
Anemia  3/156 (1.92%)  0/152 (0.00%)  2/151 (1.32%)  1/157 (0.64%) 
Cardiac disorders         
Cardiac Failure  17/156 (10.90%)  18/152 (11.84%)  20/151 (13.25%)  15/157 (9.55%) 
Cardiac Failure Acute  13/156 (8.33%)  6/152 (3.95%)  9/151 (5.96%)  10/157 (6.37%) 
Ventricular Tachycardia  7/156 (4.49%)  4/152 (2.63%)  7/151 (4.64%)  4/157 (2.55%) 
Acute Myocardial Infarction  4/156 (2.56%)  1/152 (0.66%)  4/151 (2.65%)  1/157 (0.64%) 
Cardiac Arrest  3/156 (1.92%)  3/152 (1.97%)  3/151 (1.99%)  3/157 (1.91%) 
Angina Pectoris  2/156 (1.28%)  1/152 (0.66%)  2/151 (1.32%)  1/157 (0.64%) 
Atrial Fibrillation  1/156 (0.64%)  2/152 (1.32%)  2/151 (1.32%)  1/157 (0.64%) 
Atrial Tachycardia  1/156 (0.64%)  1/152 (0.66%)  1/151 (0.66%)  1/157 (0.64%) 
Cardiac Failure Chronic  1/156 (0.64%)  3/152 (1.97%)  2/151 (1.32%)  2/157 (1.27%) 
Cardiogenic Shock  1/156 (0.64%)  0/152 (0.00%)  1/151 (0.66%)  0/157 (0.00%) 
Myocardial Infarction  1/156 (0.64%)  0/152 (0.00%)  0/151 (0.00%)  1/157 (0.64%) 
Ventricular Arrhythmia  1/156 (0.64%)  1/152 (0.66%)  2/151 (1.32%)  0/157 (0.00%) 
Infections and infestations         
Sepsis  3/156 (1.92%)  4/152 (2.63%)  5/151 (3.31%)  2/157 (1.27%) 
Metabolism and nutrition disorders         
Hyperkalaemia  2/156 (1.28%)  6/152 (3.95%)  3/151 (1.99%)  5/157 (3.18%) 
Nervous system disorders         
Cerebrovascular Accident  2/156 (1.28%)  2/152 (1.32%)  3/151 (1.99%)  1/157 (0.64%) 
Renal and urinary disorders         
Renal Failure  5/156 (3.21%)  6/152 (3.95%)  7/151 (4.64%)  4/157 (2.55%) 
Renal Failure Acute  3/156 (1.92%)  5/152 (3.29%)  6/151 (3.97%)  2/157 (1.27%) 
Renal Failure Chronic  0/156 (0.00%)  1/152 (0.66%)  0/151 (0.00%)  1/157 (0.64%) 
Vascular disorders         
Hypotension  7/156 (4.49%)  9/152 (5.92%)  11/151 (7.28%)  5/157 (3.18%) 
Arterial Thrombosis Limb  1/156 (0.64%)  0/152 (0.00%)  1/151 (0.66%)  0/157 (0.00%) 
Deep Vein Thrombosis  1/156 (0.64%)  0/152 (0.00%)  1/151 (0.66%)  0/157 (0.00%) 
Shock Haemorrhagic  0/156 (0.00%)  1/152 (0.66%)  1/151 (0.66%)  0/157 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Q 12 Hour Bolus Continuous Infusion Low Intensification High Intensification
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
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: Jeff Sharp
Organization: Duke University
Phone: 919.668.7086
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00577135     History of Changes
Other Study ID Numbers: Pro00017634
U01HL084904-01 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2007
First Posted: December 19, 2007
Results First Submitted: January 23, 2013
Results First Posted: May 27, 2013
Last Update Posted: March 6, 2018