BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.

Mayo Clinic

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acute Kidney Failure

Treatments

Drug: Neseritide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00252200

621-03

Details and patient eligibility

About

Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.