Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Neonates and infants undergoing heart surgery with cardiopulmonary bypass and cardioplegic arrest experience both inflammation and myocardial ischemia-reperfusion [IR] injury. These processes provoke myocardial apoptosis and oxygen free radical formation which result in cardiac injury and dysfunction. Dexrazoxane [DRZ] is a derivative of EDTA that is approved for prevention of anthracycline-related cardiotoxicity. It provides cardioprotection through reduction of toxic reactive oxygen species [ROS], and suppression of apoptosis. The investigators propose a 12-patient pilot to determine DRZ pharmacokinetics, and to collect additional safety data in the neonatal and infant population. Efficacy of cardioprotection will not be evaluated in this preliminary investigation, though the investigators will determine postoperative time to resolution of organ failure, development of low cardiac output syndrome, length of cardiac ICU and hospital stays, laboratory indices of myocardial injury and systemic inflammation, and echocardiographic cardiac dysfunction for safety purposes, and as a run-in to the larger, randomized, placebo controlled trial. Conducting this pilot could optimize team execution of the study protocol. In addition, results could further establish the safety of DRZ in the neonatal and infant populations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04997291
Study type Interventional
Source University of Texas at Austin
Contact Daniel Stromberg, MD
Phone 512-324-3357
Email dstromberg@austin.utexas.edu
Status Recruiting
Phase Phase 1
Start date April 9, 2021
Completion date January 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05330338 - Genetics of Ventriculo-arterial Discordance N/A
Withdrawn NCT03405636 - Xeltis Pulmonary Valved Conduit Safety and Performance Study N/A
Completed NCT02443662 - Colloid Osmotic Pressure in Patients With Fontan Circulation
Terminated NCT02519335 - Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation Phase 1
Completed NCT01835392 - Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery N/A
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Completed NCT03035552 - CTICU Pacifier Activated Music Player and Mother's Voice N/A
Recruiting NCT04581668 - Impact of NAVA Ventilation on Brain Oxygenation and Perfusion in Children With Congenital Heart Disease N/A
Enrolling by invitation NCT04866537 - Evaluation of the Diagnostic Performance of Specialized Fetal Cardiac Ultrasound in the CPDPN - Arc Alpin Network
Completed NCT03049540 - Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function Phase 3
Completed NCT02377674 - Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection N/A
Completed NCT01679275 - Pre-operative Cerebral Oxygenation in Neonates With Congenital Heart Disease
Terminated NCT00543309 - Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery Phase 2
Completed NCT03957512 - Livet Skal Leves (A Life to Live)
Recruiting NCT06005428 - Effectiveness of CRD-4730 in Participants With Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Phase 2
Recruiting NCT02691689 - Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions N/A
Completed NCT02306057 - Fluid Balance in Children Undergoing Fontan Surgery N/A
Recruiting NCT02157597 - NIRS Guidance Trail in Children's Heart Surgery N/A
Completed NCT01570933 - Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants. Phase 4
Completed NCT00443599 - SPECS: Safe Pediatric Euglycemia in Cardiac Surgery N/A