Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Cardiopulmonary bypass and arrest of the heart during cardiac surgery are necessary to allow the surgeon to perform heart operations. However, these processes can cause injury to the heart which may worsen post-operative outcomes. In fact, the effects of these injuries may continue after surgery, and lead to a long-term decrease in heart function. Neonates and young infants are at particular risk for this occurrence.

While much research has been done in adults looking for medicines that might protect the heart during surgery, few studies have been conducted in neonates and young infants. The investigators are testing Dexrazoxane, which has proven to be cardio-protective in pediatric cancer patients, in the hope that it may lessen cardiac injury during and after congenital heart surgery, and thereby improve outcomes in the neonatal and young infant population.

In order to accomplish this, the investigators must first determine how Dexrazoxane can be safely administered to young children with congenital heart disease. Therefore, the investigators are performing a pilot study of 12 children to assess:

1. how Dexrazoxane at 3 different doses is metabolized in the body of a child age 0-6 months during and after congenital heart surgery, and

2. the safety of Dexrazoxane use in the neonatal and young infant population undergoing cardiac surgery.

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

Details

• Lead Sponsor: Medical City Children's Hospital
• Collaborator: Mylan Pharmaceuticals
• Treatments: Dexrazoxane; Razoxane

Criteria

Inclusion Criteria:

• age 6 months and under

• open heart surgery requiring CPB and use of cardioplegia

• parent/guardian consent for study obtained surgery planned Monday to Friday

Exclusion Criteria:

• gestational age <36weeks

• known syndrome or genetic abnormality, except Trisomy 21 single ventricle physiology

• concurrent enrollment in another research protocol

• no parental/guardian consent obtained

• ECMO utilization prior to surgery or necessary at the time of ICU admission