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

Phase 1

Completed

• Conditions: Acute Kidney Failure

• Registration Number: NCT00252200
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-11
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-22
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula	72 hours post op

Secondary Outcome Measures

Name	Time	Method
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
Need or absence of need for inotropic support in the 72 hour perioperative period	72 hours perioperative

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States