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

This study has been completed.
Scios, Inc.
Information provided by:
Mayo Clinic Identifier:
First received: November 10, 2005
Last updated: September 22, 2009
Last verified: September 2009
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

Condition Intervention Phase
Acute Kidney Failure Drug: Neseritide Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula [ Time Frame: 72 hours post op ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: March 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Neseritide
    Dose of Nesiritide infusion will be 0.005 ug/Kg/min
    Other Name: BNP, Nesiritide
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00252200

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Scios, Inc.
Principal Investigator: Horng H. Chen, M.D. Mayo Clinic
  More Information

Responsible Party: Horng H. Chen, Mayo Clinic Rochester Identifier: NCT00252200     History of Changes
Other Study ID Numbers: 621-03
Study First Received: November 10, 2005
Last Updated: September 22, 2009

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs processed this record on August 18, 2017