BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.|
- Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula [ Time Frame: 72 hours post op ] [ Designated as safety issue: No ]
- Number of patients requiring dialysis during the hospitalization [ Time Frame: before hospital discharge ] [ Designated as safety issue: No ]
- Plasma aldosterone levels at 12 hours and 24 hours [ Time Frame: 12 hours and 24 hours postoperatively ] [ Designated as safety issue: No ]
- Total time on ventilator, ICU length of stay, total length of stay in hospital [ Time Frame: total length of hospital stay ] [ Designated as safety issue: No ]
- pre and postoperative diuretic dose used [ Time Frame: pre operative and postoperate ] [ Designated as safety issue: No ]
- Need or absence of need for inotropic support in the 72 hour perioperative period [ Time Frame: 72 hours perioperative ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.