Status:
TERMINATED
Nesiritide Use Following Cardiac Surgery in Infants
Lead Sponsor:
Boston Children's Hospital
Conditions:
Heart Defects, Congenital
Cardiopulmonary Bypass
Eligibility:
All Genders
Up to 1 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
Nesiritide, a recombinant human B-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated ...
Eligibility Criteria
Inclusion
- \> 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
- 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.
Key Trial Info
Start Date :
April 8 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00281671
Start Date
April 8 2006
End Date
October 1 2008
Last Update
August 27 2020
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115