Back to resultsBNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
Primary Purpose
Acute Kidney Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Neseritide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Failure
Eligibility 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.
Sites / Locations
- Mayo Clinic
Outcomes
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
Full Information
NCT ID
NCT00252200
First Posted
November 10, 2005
Last Updated
September 22, 2009
Sponsor
Mayo Clinic
Collaborators
Scios, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00252200
Brief Title
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
Official Title
Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Scios, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Neseritide
Other Intervention Name(s)
BNP, Nesiritide
Intervention Description
Dose of Nesiritide infusion will be 0.005 ug/Kg/min
Primary Outcome Measure Information:
Title
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
Time Frame
72 hours post op
Secondary Outcome Measure Information:
Title
Number of patients requiring dialysis during the hospitalization
Time Frame
before hospital discharge
Title
Plasma aldosterone levels at 12 hours and 24 hours
Time Frame
12 hours and 24 hours postoperatively
Title
Total time on ventilator, ICU length of stay, total length of stay in hospital
Time Frame
total length of hospital stay
Title
pre and postoperative diuretic dose used
Time Frame
pre operative and postoperate
Title
Need or absence of need for inotropic support in the 72 hour perioperative period
Time Frame
72 hours perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horng H. Chen, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
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