Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery
NCT ID: NCT04997291
Last Updated: 2021-08-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE1
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-04-09
Study Completion Date
2022-01-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Heart Defects, Congenital
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Dexrazoxane
Group Type
EXPERIMENTAL
Dexrazoxane
Intervention Type
DRUG
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).
Interventions
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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).
Intervention Type
DRUG
Other Intervention Names
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Zinecard
Eligibility Criteria
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Inclusion Criteria
* age ≤ 1 year
* open heart surgery requiring CPB and use of cardioplegia
* parent/guardian consent for study obtained
* surgery planned Monday-Friday
* 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
* known syndrome or genetic abnormality, except Trisomy 21
* single ventricle physiology
* concurrent enrollment in another research protocol
Minimum Eligible Age
0 Years
Maximum Eligible Age
1 Year
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dell Children's Medical Center of Central Texas
OTHER
Sponsor Role
collaborator
University of Texas at Austin
OTHER
Sponsor Role
lead
Responsible Party
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Daniel Stromberg
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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References
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Other Identifiers
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2020-02-0075
Identifier Type: -
Identifier Source: org_study_id
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