Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
Study Overview
Brief Summary
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
Detailed Description
This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients > 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance < 50 ml/min and who are not dialysis dependent.
Exclusion Criteria
- •Cardiogenic shock or hypotension with systolic BP < 90 mmHg.
- •Patients with acute or chronic aortic dissection.
- •Patients who are enrolled in other studies that have an effect the renal function.
Outcomes
Primary Outcomes
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
Time Frame: 72 hours post op
Secondary Outcomes
- Need or absence of need for inotropic support in the 72 hour perioperative period(72 hours perioperative)
- Number of patients requiring dialysis during the hospitalization(before hospital discharge)
- Plasma aldosterone levels at 12 hours and 24 hours(12 hours and 24 hours postoperatively)
- Total time on ventilator, ICU length of stay, total length of stay in hospital(total length of hospital stay)
- pre and postoperative diuretic dose used(pre operative and postoperate)