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

September 22, 2009 updated by: Mayo Clinic

Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.

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

Study Overview

Status

Completed

Conditions

Acute Kidney Failure

Intervention / Treatment

Drug: Neseritide

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula Time Frame: 72 hours post op	72 hours post op

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients requiring dialysis during the hospitalization Time Frame: before hospital discharge	before hospital discharge
Plasma aldosterone levels at 12 hours and 24 hours Time Frame: 12 hours and 24 hours postoperatively	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	total length of hospital stay
pre and postoperative diuretic dose used Time Frame: pre operative and postoperate	pre operative and postoperate
Need or absence of need for inotropic support in the 72 hour perioperative period Time Frame: 72 hours perioperative	72 hours perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Scios, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)