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

Mayo Clinic40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Kidney Failure

Interventions

NeseritideDRUG

Dose of Nesiritide infusion will be 0.005 ug/Kg/min

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula

Time frame: 72 hours post op

Secondary Outcomes

Number of patients requiring dialysis during the hospitalization

Time frame: before hospital discharge

Plasma aldosterone levels at 12 hours and 24 hours

Time frame: 12 hours and 24 hours postoperatively

Total time on ventilator, ICU length of stay, total length of stay in hospital

Time frame: total length of hospital stay

pre and postoperative diuretic dose used

Time frame: pre operative and postoperate

Need or absence of need for inotropic support in the 72 hour perioperative period

Time frame: 72 hours perioperative

Data from ClinicalTrials.gov

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