Effects of Nesiritide in Pediatric Patients With Heart Failure

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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. The Food and Drug Administration (FDA) encourages clinical studies of drugs in children to further extend appropriate use of new medicines.

This study involves nesiritide, which was approved as a congestive heart failure treatment in adults in August 2001. The investigators' use of this drug in a pediatric population with severe heart failure has been encouraging. The investigators now wish to formally determine the pharmacokinetic and safety of Nesiritide in children.

The investigators will enroll 30 patients who are in the cardiac intensive care unit with severe heart failure. The data collected will include weights, vital signs, laboratory results, and echocardiography results. A research lab test called B-type natriuretic peptide (BNP) will be done several times during this study. If the patient still has an intravenous (IV) catheter, the blood sample will be taken from the IV. If the patient does not have an IV, the sample will be taken from a fingerstick.

The duration of the study will be the first 2 days of the patient's stay in the cardiac intensive care unit and thru discharge to evaluate the endpoint safety of Nesiritide. Additional information will also be collected if patient gets re-admitted within 30 days of discharge.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Children's Healthcare of Atlanta
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

1. Age newborn to 18 years.

2. 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.

3. Receiving or about to receive nesiritide as medical therapy.

4. Informed consent will be signed by parent or guardian for all patients. (assent if applicable).

Exclusion Criteria:

1. Patients requiring extra corporeal membrane oxygenation (ECMO) support.

2. Patients requiring central veno-venous hemofiltration (CVVH).

3. Patients that are pregnant

4. Parent or legal guardian (or patient when applicable) refuses to sign informed consent.