Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
- Registration Number
- NCT00119691
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures
- Admission estimated creatinine clearance =< 50 cc/min.
Exclusion Criteria
- Systolic blood pressure < 85 mm Hg
- Cardiogenic shock
- Volume depletion
- Myocardial infarction, unstable angina within last 30 days
- Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis
- Chronic hemodialysis
- Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation
- Enrolled in another research protocol within last 30 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care Nesiritide Standard of care until adequate diuresis achieved Nesiritide + standard of care Nesiritide Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.
- Primary Outcome Measures
Name Time Method Renal function within 7 days after randomization
- Secondary Outcome Measures
Name Time Method Weight loss Within 7 days from randomization Days to optimal volume status From randomization till day 7 or sooner Concomitant diuretic use Within 7 days from randomization Global symptom assessment 24 hrs and 3 days after randomization Length of stay From admission to discharge or day 7
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States