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.

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252200

Enrollment

Registered

2005-11-11

Start date

2003-03-31

Completion date

2007-10-31

Last updated

2009-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Failure

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.

Interventions

DRUGNeseritide

Dose of Nesiritide infusion will be 0.005 ug/Kg/min

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula	72 hours post op

Secondary

Measure	Time frame
Number of patients requiring dialysis during the hospitalization	before hospital discharge
Plasma aldosterone levels at 12 hours and 24 hours	12 hours and 24 hours postoperatively
Total time on ventilator, ICU length of stay, total length of stay in hospital	total length of hospital stay
pre and postoperative diuretic dose used	pre operative and postoperate
Need or absence of need for inotropic support in the 72 hour perioperative period	72 hours perioperative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026