Recruiting
Phase 1

Dexrazoxane

Sponsor:

University of Texas at Austin

Code:

NCT04997291

Conditions

Heart Defects, Congenital

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Dexrazoxane

Study Details

Brief 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.

Conditions

Heart Defects, Congenital

Study ID

NCT04997291

Start date

Apr 9, 2021

Status verified date

Aug, 2021

Completion date

Jan, 2022

Anticipated

Primary completion date

Oct, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age ≤ 1 year
  • open heart surgery requiring CPB and use of cardioplegia
  • parent/guardian consent for study obtained
  • surgery planned Monday-Friday

Exclusion Criteria:

  • gestational age <36 weeks at time of enrollment
  • known syndrome or genetic abnormality, except Trisomy 21
  • single ventricle physiology
  • concurrent enrollment in another research protocol

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dexrazoxane

Interventions

Dexrazoxane

Twelve enrollees will be consecutively assigned to a dosing regimen of 400 mg/m2/dose. The medication will be administered in the operating room 30 minutes prior to starting cardiopulmonary bypass (dose #1), prior to aortic cross clamp removal (dose #2), and on the morning after surgery in the cardiac intensive care unit (dose #3).

Primary outcome measure

  • Peak Plasma Concentration (Cmax) [ Time Frame: 24 hours ]
  • Area under the plasma concentration vs time curve (AUC) [ Time Frame: 24 hours ]
  • Minimum plasma concentration (Cmin) [ Time Frame: 24 hours ]
  • Time to resolution of organ failure [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Daniel Stromberg, MD

512-324-3357dstromberg@austin.utexas.edu

Jacob Strelow, MPH

757-268-2691strelow.jacob@austin.utexas.edu

Locations

Dell Children's Medical Center of Central Texas

Recruiting

Austin, Texas, United States, 78723

More Information

Sponsor

University of Texas at Austin

Last update posted

Aug 9, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2021-08-09.