Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery: Proposal for Pilot Investigation
NCT ID: NCT02519335
Last Updated: 2018-07-26
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
TERMINATED
Clinical Phase
PHASE1
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-09-30
Study Completion Date
2017-03-31
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. 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.
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.
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Detailed Description
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Neonates and infants undergoing heart surgery with 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 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 deleterious effects of cardiopulmonary bypass \[CPB\] with cardioplegic arrest of the heart during congenital heart operations greatly influence postoperative morbidity and mortality. Neonates and infants undergoing cardiac surgery experience both a systemic inflammatory response, and myocardial IR injury as cardioplegic arrest is reversed. These processes provoke elaboration of cytokines and activation of the complement cascade, as well as oxygen free radical formation and induction of myocardial apoptosis (1, 2, 3). Frequently, myocardial injury and cardiac dysfunction ensue, leading to low cardiac output syndrome and multi-system organ failure. The irreversible component of these injuries, in addition to the abnormal workloads imposed on the myocardium from the anatomic defects themselves, may have consequences for long-term cardiac function, and may in part explain contractile dysfunction observed late after congenital heart
The investigators propose a pilot pharmacokinetic/safety trial of dexrazoxane in children 0-6 months of age, followed by a randomized, double-blind, clinical trial of dexrazoxane vs placebo during congenital heart surgery. The investigators will evaluate postoperative time to resolution of organ failure, development of low cardiac output syndrome, length of cardiac ICU and hospital stays, and echocardiographic indices of cardiac dysfunction. Results could establish the safety and clinical utility of dexrazoxane in ameliorating ischemia-reperfusion injury during congenital heart surgery.
The deleterious effects of cardiopulmonary bypass \[CPB\] with cardioplegic arrest of the heart during congenital heart operations greatly influence postoperative morbidity and mortality. Neonates and infants undergoing cardiac surgery experience both a systemic inflammatory response, and myocardial IR injury as cardioplegic arrest is reversed. These processes provoke elaboration of cytokines and activation of the complement cascade, as well as oxygen free radical formation and induction of myocardial apoptosis (1, 2, 3). Frequently, myocardial injury and cardiac dysfunction ensue, leading to low cardiac output syndrome and multi-system organ failure. The irreversible component of these injuries, in addition to the abnormal workloads imposed on the myocardium from the anatomic defects themselves, may have consequences for long-term cardiac function, and may in part explain contractile dysfunction observed late after congenital heart
The investigators propose a pilot pharmacokinetic/safety trial of dexrazoxane in children 0-6 months of age, followed by a randomized, double-blind, clinical trial of dexrazoxane vs placebo during congenital heart surgery. The investigators will evaluate postoperative time to resolution of organ failure, development of low cardiac output syndrome, length of cardiac ICU and hospital stays, and echocardiographic indices of cardiac dysfunction. Results could establish the safety and clinical utility of dexrazoxane in ameliorating ischemia-reperfusion injury during congenital heart surgery.
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
Trial subjects will be assigned preoperatively to receive Dexrazoxane at one of three doses: low (200mg/m2/dose), medium (300mg/m2/dose), or high (400mg/m2/dose). Four patients will be assigned to each dosing regimen for a total of 12 patients.
The medication will be administered in the operating room 15-30 minutes prior to starting cardiopulmonary bypass (dose #1), after finishing cardiopulmonary bypass (dose #2), and on the morning after surgery in the cardiac intensive care unit (dose #3).
Group Type
OTHER
Dexrazoxane
Intervention Type
DRUG
Dose escalation every 4 subjects from 200mg/m2/dose; 300mg/m2/dose to 400mg/m2/dose
Interventions
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Dexrazoxane
Dose escalation every 4 subjects from 200mg/m2/dose; 300mg/m2/dose to 400mg/m2/dose
Intervention Type
DRUG
Other Intervention Names
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Zinecard
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
1 Day
Maximum Eligible Age
6 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Mylan Pharmaceuticals Inc
INDUSTRY
Sponsor Role
collaborator
Medical City Children's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Daniel Stromberg, MD
Role: PRINCIPAL_INVESTIGATOR
Medical City Children's Hospital
Locations
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Medical City Children's Hospital
Dallas, Texas, United States
Site Status
Countries
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United States
References
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Other Identifiers
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MCCH-001
Identifier Type: -
Identifier Source: org_study_id
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