Trial Outcomes & Findings for Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study (NCT NCT01132846)
NCT ID: NCT01132846
Last Updated: 2014-08-21
Results Overview
The primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
360 participants
Primary outcome timeframe
Randomization to 72 hours
Results posted on
2014-08-21
Participant Flow
Participant milestones
| Measure |
Low Dose Dopamine
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Overall Study
STARTED
|
122
|
119
|
119
|
|
Overall Study
COMPLETED
|
106
|
101
|
108
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Renal Optimization Strategies Evaluation in Acute Heart Failure and Reliable Evaluation of Dyspnea in the Heart Failure Network (ROSE) Study
Baseline characteristics by cohort
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
68.3 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
344 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Randomization to 72 hoursThe primary Safety endpoint is change in serum cystatin C from randomization to 72 hours.
Outcome measures
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Cystatin C
|
.12 mg/L
Standard Deviation .32
|
.11 mg/L
Standard Deviation .27
|
.07 mg/L
Standard Deviation .34
|
PRIMARY outcome
Timeframe: Baseline to 72 hoursTo determine whether the pDSS is a more sensitive index of variability in dyspnea status than the dyspnea VAS assessed without standardization of conditions at assessment as assessed by change in Dyspnea VAS. Dyspnea VAS range -100 to + 100 Larger number is better
Outcome measures
| Measure |
Low Dose Dopamine
n=70 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=70 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=73 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Dyspnea Assessment (RED-ROSE Substudy)
|
16.1 units on a scale
Standard Deviation 30.7
|
16.2 units on a scale
Standard Deviation 22.3
|
16.8 units on a scale
Standard Deviation 24.2
|
PRIMARY outcome
Timeframe: Baseline to 72 hoursPopulation: RED-ROSE is a substudy of the overall ROSE study. Only consented and enrolled RED-ROSE subjects participated.
To determine whether changes in pDSS or dyspnea VAS are related to the response to decongestive therapy as evidenced by fluid volume loss Fluid volume loss is defined as cumulative urinary output minus fluid intake during the first 72 hours post randomization.
Outcome measures
| Measure |
Low Dose Dopamine
n=74 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=72 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=72 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Decongestive Changes- RED-ROSE
|
4526.0 mL
Standard Deviation 3191.9
|
4659.9 mL
Standard Deviation 2862.5
|
5177.2 mL
Standard Deviation 2830.5
|
PRIMARY outcome
Timeframe: Randomization to 72 hoursThe primary efficacy endpoint is cumulative urinary volume (UV; +/- indwelling urinary catheter) at 72 hours
Outcome measures
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Cumulative Urinary Volume
|
8524 mL
Standard Deviation 3418
|
8296 mL
Standard Deviation 2973
|
8574 mL
Standard Deviation 3115
|
SECONDARY outcome
Timeframe: randomization to 72 hoursChange in weight from randomization to 72 hours. Secondary Endpoint
Outcome measures
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Weight
|
-7.40 lbs
Standard Deviation 7.94
|
-7.73 lbs
Standard Deviation 7.04
|
-7.15 lbs
Standard Deviation 7.80
|
SECONDARY outcome
Timeframe: Change from Baseline to 72 hoursPopulation: RED-ROSE was a substudy of the main ROSE study. Only subjects consented and enrolled in RED-ROSE were included in this analysis.
To determine whether changes in worst reported symptom (WRS) (dyspnea, body swelling or fatigue) VAS (WRS-VAS) are related to the response to decongestive therapy as assessed by change in WRS VAS. WRS range -100 to + 100 Higher number is better (improved)
Outcome measures
| Measure |
Low Dose Dopamine
n=68 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=70 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=73 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Worst Reported Symptom Changes-RED-ROSE
|
20.9 units on a scale
Standard Deviation 29.6
|
19.6 units on a scale
Standard Deviation 22.7
|
25.6 units on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: Baseline to 60 daysPopulation: RED-ROSE was a substudy of the main ROSE trial. Only subjects consented and enrolled in RED-ROSE were included in this analysis.
Change in clinical stability as assessed by 60 day death, re-hospitalization or unscheduled outpatient visit
Outcome measures
| Measure |
Low Dose Dopamine
n=76 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=75 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=76 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Clinical Stability- RED-ROSE
|
30 participants
|
34 participants
|
27 participants
|
SECONDARY outcome
Timeframe: randomization to 72 hoursOutcome measures
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Serum Creatinine
|
0.00 mg/dL
Standard Deviation 0.44
|
0.02 mg/dL
Standard Deviation 0.33
|
0.02 mg/dL
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: randomization to 72 hoursPopulation: Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Range 0 to 7200 Higher is better
Outcome measures
| Measure |
Low Dose Dopamine
n=112 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=114 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=115 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Dyspnea Visual Analog Scale Area Under the Curve
|
4935.8 units on a scale * hours
Standard Deviation 1472.1
|
4997.6 units on a scale * hours
Standard Deviation 1479.9
|
4831.4 units on a scale * hours
Standard Deviation 1294.1
|
SECONDARY outcome
Timeframe: randomization to 72 hoursPopulation: Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Persistent or worsening heart failure defined as need for rescue therapy.
Outcome measures
| Measure |
Low Dose Dopamine
n=118 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=116 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=117 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Heart Failure Status
|
11 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: randomization to 72 hoursPopulation: Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Treatment failure including any of the following: * development of cardio-renal syndrome * worsening/persistent heart failure * significant hypotension requiring discontinuation of study drug * significant tachycardia requiring discontinuation of study drug death
Outcome measures
| Measure |
Low Dose Dopamine
n=117 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=115 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Treatment Response
|
35 participants
|
32 participants
|
48 participants
|
SECONDARY outcome
Timeframe: Randomization to 72 hoursOutcome measures
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Cumulative Urinary Sodium Excretion
|
527.0 mmol
Standard Deviation 299.0
|
539.8 mmol
Standard Deviation 302.7
|
515.2 mmol
Standard Deviation 261.4
|
SECONDARY outcome
Timeframe: Randomization to 72 hoursBUN measured in mg/dL Cystatin C measured in mg/L No units were used in calculated the ratio
Outcome measures
| Measure |
Low Dose Dopamine
n=122 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Change in Blood Urea Nitrogen (BUN)/ Serum Cystatin C Ratio
|
-2.34 ratio
Standard Deviation 25.33
|
0.23 ratio
Standard Deviation 5.16
|
0.74 ratio
Standard Deviation 7.60
|
SECONDARY outcome
Timeframe: Randomization to 72 hoursPopulation: Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Outcome measures
| Measure |
Low Dose Dopamine
n=105 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=110 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=111 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Development of Cardio-renal Syndrome
|
23 participants
|
24 participants
|
28 participants
|
SECONDARY outcome
Timeframe: Randomization to 72 hoursPopulation: Based upon data completeness, sample size for this endpoint does not match the overall ROSE population.
Range 0 to 7200 Higher is better/improved
Outcome measures
| Measure |
Low Dose Dopamine
n=112 Participants
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=113 Participants
Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=114 Participants
Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Global Visual Analog Scale Area Under the Curve
|
4553.4 units on a scale * hours
Standard Deviation 1324.9
|
4703.6 units on a scale * hours
Standard Deviation 1403.4
|
4498.3 units on a scale * hours
Standard Deviation 1301.5
|
Adverse Events
Low Dose Dopamine
Serious events: 30 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 24 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose Nesiritide
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose Dopamine
n=122 participants at risk
Drug: Dopamine
Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study
Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
|
Placebo
n=119 participants at risk
Drug: Placebo
Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.
Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
|
Low Dose Nesiritide
n=119 participants at risk
Drug: Nesiritide
Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.
Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.82%
1/122
|
1.7%
2/119
|
0.00%
0/119
|
|
Blood and lymphatic system disorders
Hemorrhagic Anemia
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Cardiac disorders
Atrioventricular Block, Second Degree
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Cardiac disorders
Cardiac Arrest
|
1.6%
2/122
|
1.7%
2/119
|
0.00%
0/119
|
|
Cardiac disorders
Paroxysmal Arrhythmia
|
0.00%
0/122
|
0.84%
1/119
|
0.00%
0/119
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.00%
0/122
|
1.7%
2/119
|
0.00%
0/119
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Eye disorders
Visual Impairment
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Gastrointestinal disorders
Diarrhea
|
0.82%
1/122
|
0.84%
1/119
|
0.00%
0/119
|
|
Gastrointestinal disorders
Gastroesophogeal Reflux Disease
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
0.82%
1/122
|
1.7%
2/119
|
0.84%
1/119
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Gastrointestinal disorders
Upper Gastrointestinal Hemorrhage
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Gastrointestinal disorders
Vomitting
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
General disorders
Infusion Site Irritation
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
General disorders
Chest Discomfort
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
General disorders
Chest Pain
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
General disorders
Death
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Infections and infestations
Cellulitis
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Infections and infestations
Influenza
|
1.6%
2/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/122
|
0.84%
1/119
|
0.00%
0/119
|
|
Infections and infestations
Pneumonia
|
1.6%
2/122
|
0.84%
1/119
|
0.84%
1/119
|
|
Infections and infestations
Sepsis
|
3.3%
4/122
|
1.7%
2/119
|
0.00%
0/119
|
|
Infections and infestations
Septic Shock
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/122
|
0.84%
1/119
|
0.00%
0/119
|
|
Injury, poisoning and procedural complications
Procedural Complications
|
0.82%
1/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Investigations
Anticoagulation Drug Level Above Therapeutic
|
1.6%
2/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Investigations
Weight Decreased
|
0.00%
0/122
|
0.84%
1/119
|
0.00%
0/119
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
2/122
|
0.84%
1/119
|
0.84%
1/119
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.82%
1/122
|
0.84%
1/119
|
0.84%
1/119
|
|
Nervous system disorders
Syncope
|
0.00%
0/122
|
1.7%
2/119
|
1.7%
2/119
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/122
|
0.00%
0/119
|
0.84%
1/119
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/122
|
2.5%
3/119
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.6%
2/122
|
0.00%
0/119
|
0.00%
0/119
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.6%
2/122
|
0.84%
1/119
|
0.00%
0/119
|
|
Vascular disorders
Hypotension
|
1.6%
2/122
|
5.9%
7/119
|
4.2%
5/119
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place