Nesiritide Use Following Cardiac Surgery in Infants

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• > 48 hours after cardiac surgery requiring cardiopulmonary bypass

• < 1 year of age

• Receiving chlorothiazide and furosemide for > 12 hours

• Urine output < 4 cc/kg/hour, or fluid intake > output for 2 consecutive days

• Receiving mechanical ventilation

• Presence of body wall edema on CXR, defined as a radiologic index of > 2

• Plan for > 24 hrs further diuresis before chest closure or extubation

Exclusion Criteria:

• Age > 365 days at the time of enrollment

• Corrected estimated gestational age < 35 weeks at the time of enrollment

• Serum creatinine > 2.0 mg/dL at the time of enrollment

• Significant hemodynamic instability at the time of enrollment

• Lack of dedicated intravenous access for nesiritide infusion

• Lack of arterial line for continuous blood pressure monitoring

• Lack of a Foley catheter for continuous urine collection

• Enrollment in another research study such that the outcomes of either study may be confounded by participation in this study, or such that the amount of blood drawn for research purposes becomes excessive.