Status:
WITHDRAWN
Effects of Nesiritide in Pediatric Patients With Heart Failure
Lead Sponsor:
Emory University
Collaborating Sponsors:
Children's Healthcare of Atlanta
Conditions:
Heart Failure
Ventricular Dysfunction
Eligibility:
All Genders
1-18 years
Phase:
NA
Brief Summary
Children with severe heart failure need immediate appropriate care. New and better drugs are constantly being developed. As these drugs are approved for adult use, they are used off-label for children...
Detailed Description
Nesiritide (human recombinant B-type natriuretic peptide) has been recently approved by the Food and Drug Administration for the intravenous treatment of patients with decompensated congestive heart f...
Eligibility Criteria
Inclusion
- Age newborn to 18 years.
- Patients admitted to the CICU at Children's Healthcare of Atlanta in heart failure defined as decreased cardiac function and/or volume overload or admitted to the CICU at Children's Healthcare of Atlanta post-operatively after congenital heart defect repair surgery with increasing filling pressures and decreased ventricular compliance as seen by intracardiac line monitoring and echocardiography.
- Receiving or about to receive nesiritide as medical therapy.
- Informed consent will be signed by parent or guardian for all patients. (assent if applicable).
Exclusion
- Patients requiring extra corporeal membrane oxygenation (ECMO) support.
- Patients requiring central veno-venous hemofiltration (CVVH).
- Patients that are pregnant
- Parent or legal guardian (or patient when applicable) refuses to sign informed consent.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00166010
Start Date
October 1 2004
End Date
June 1 2010
Last Update
June 5 2014
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