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Completed

NCT Number: NCT00252200

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

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

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Key information

Conditions

Acute Kidney Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neseritide

Drug

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

Other names: BNP, Nesiritide

Primary outcomes

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

    Time frame: 72 hours post op

Secondary outcomes

  1. Number of patients requiring dialysis during the hospitalization

    Time frame: before hospital discharge

  2. Plasma aldosterone levels at 12 hours and 24 hours

    Time frame: 12 hours and 24 hours postoperatively

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

    Time frame: total length of hospital stay

  4. pre and postoperative diuretic dose used

    Time frame: pre operative and postoperate

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

    Time frame: 72 hours perioperative

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Scios, Inc.

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Nov 11, 2005
Registry last updated
Sep 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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