BNP (Nesiritide) Vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery. - Full Text View

Sponsors and Collaborators:	Mayo Clinic Scios, Inc.
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00252200

Purpose

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

Condition	Intervention	Phase
Acute Kidney Failure	Drug: BNP (Nesiritide)	Phase I Phase II

MedlinePlus related topics: Coronary Artery Bypass Surgery Kidney Failure

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Number of patients requiring dialysis during the hospitalization
Plasma aldosterone levels at 12 hours and 24 hours
Total time on ventilator, ICU length of stay, total length of stay in hospital
pre and postoperative diuretic dose used
Need or absence of need for inotropic support in the 72 hour perioperative period

Estimated Enrollment:	40
Study Start Date:	March 2003
Estimated Study Completion Date:	March 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 60 ml/min determined by the Cockroft-Gault formula, undergoing cardiopulmonary bypass surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252200

Locations

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

Sponsors and Collaborators

Mayo Clinic

Scios, Inc.

Investigators

Principal Investigator:

Horng H. Chen, M.D.

Mayo Clinic

More Information

Study ID Numbers:	621-03
Study First Received:	November 10, 2005
Last Updated:	November 10, 2005
ClinicalTrials.gov Identifier:	NCT00252200
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Acute

Kidney Diseases
Kidney Failure, Acute
Kidney Failure

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009