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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2007-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acute Kidney Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Neseritide

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

Intervention Type DRUG

Other Intervention Names

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BNP, Nesiritide

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No