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

Acute Kidney Failure Clinical Trial

Official title:

Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252200
• Other study ID #: 621-03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 10, 2005
• Last updated: September 22, 2009
• Start date: March 2003
• Est. completion date: October 2007

Study information

• Verified date: September 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Failure
• Acute Kidney Injury
• Renal Insufficiency

Intervention

Drug:
• Neseritide
Dose of Nesiritide infusion will be 0.005 ug/Kg/min

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Scios, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula		72 hours post op	No
Secondary	Number of patients requiring dialysis during the hospitalization		before hospital discharge	No
Secondary	Plasma aldosterone levels at 12 hours and 24 hours		12 hours and 24 hours postoperatively	No
Secondary	Total time on ventilator, ICU length of stay, total length of stay in hospital		total length of hospital stay	No
Secondary	pre and postoperative diuretic dose used		pre operative and postoperate	No
Secondary	Need or absence of need for inotropic support in the 72 hour perioperative period		72 hours perioperative	No