BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
This study has been completed.
Sponsor:
Mayo Clinic
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Coronary Artery Bypass Surgery
Drug Information available for:
Nesiritide
U.S. FDA Resources
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:
Detailed Description:
-
Drug: Neseritide
Dose of Nesiritide infusion will be 0.005 ug/Kg/min
Other Name: BNP, Nesiritide
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
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 May 21, 2013