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

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00252200
First received: November 10, 2005
Last updated: September 22, 2009
Last verified: September 2009
  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: Neseritide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients requiring dialysis during the hospitalization [ Time Frame: before hospital discharge ] [ Designated as safety issue: No ]
  • Plasma aldosterone levels at 12 hours and 24 hours [ Time Frame: 12 hours and 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Total time on ventilator, ICU length of stay, total length of stay in hospital [ Time Frame: total length of hospital stay ] [ Designated as safety issue: No ]
  • pre and postoperative diuretic dose used [ Time Frame: pre operative and postoperate ] [ Designated as safety issue: No ]
  • Need or absence of need for inotropic support in the 72 hour perioperative period [ Time Frame: 72 hours perioperative ] [ Designated as safety issue: No ]

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Horng H. Chen, Mayo Clinic Rochester
ClinicalTrials.gov Identifier: NCT00252200     History of Changes
Other Study ID Numbers: 621-03
Study First Received: November 10, 2005
Last Updated: September 22, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014