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

November 10, 2005
September 22, 2009
March 2003
October 2007   (final data collection date for primary outcome measure)
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula [ Time Frame: 72 hours post op ] [ Designated as safety issue: No ]
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
Complete list of historical versions of study NCT00252200 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acute Kidney Failure
Drug: Neseritide
Dose of Nesiritide infusion will be 0.005 ug/Kg/min
Other Name: BNP, Nesiritide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2007
October 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00252200
621-03
No
Horng H. Chen, Mayo Clinic Rochester
Mayo Clinic
Scios, Inc.
Principal Investigator: Horng H. Chen, M.D. Mayo Clinic
Mayo Clinic
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP