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

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ClinicalTrials.gov Identifier: NCT00252200
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : September 23, 2009
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
Mayo Clinic

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

Condition or disease Intervention/treatment Phase
Acute Kidney Failure Drug: Neseritide Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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.
Study Start Date : March 2003
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nesiritide
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: Neseritide
    Dose of Nesiritide infusion will be 0.005 ug/Kg/min
    Other Name: BNP, Nesiritide

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

Secondary Outcome Measures :
  1. Number of patients requiring dialysis during the hospitalization [ Time Frame: before hospital discharge ]
  2. Plasma aldosterone levels at 12 hours and 24 hours [ Time Frame: 12 hours and 24 hours postoperatively ]
  3. Total time on ventilator, ICU length of stay, total length of stay in hospital [ Time Frame: total length of hospital stay ]
  4. pre and postoperative diuretic dose used [ Time Frame: pre operative and postoperate ]
  5. Need or absence of need for inotropic support in the 72 hour perioperative period [ Time Frame: 72 hours perioperative ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Horng H. Chen, Mayo Clinic Rochester
ClinicalTrials.gov Identifier: NCT00252200     History of Changes
Other Study ID Numbers: 621-03
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: September 23, 2009
Last Verified: September 2009

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