Use of the Cardioprotectant Dexrazoxane During Congenital Heart Surgery
2 de agosto de 2021 actualizado por: Daniel Stromberg, University of Texas at Austin
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
12
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Daniel Stromberg, MD
- Número de teléfono: 512-324-3357
- Correo electrónico: dstromberg@austin.utexas.edu
Copia de seguridad de contactos de estudio
- Nombre: Jacob Strelow, MPH
- Número de teléfono: 757-268-2691
- Correo electrónico: strelow.jacob@austin.utexas.edu
Ubicaciones de estudio
-
-
Texas
-
Austin, Texas, Estados Unidos, 78723
- Reclutamiento
- Dell Children's Medical Center of Central Texas
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 segundo a 1 año (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concentración plasmática máxima (Cmax)
Periodo de tiempo: 24 horas
|
24 horas
|
|
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Area under the plasma concentration vs time curve (AUC)
Periodo de tiempo: 24 hours
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24 hours
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Minimum plasma concentration (Cmin)
Periodo de tiempo: 24 hours
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24 hours
|
|
|
Time to resolution of organ failure
Periodo de tiempo: 14 days
|
defined as hours to the point of being off invasive mechanical ventilation, without significant renal dysfunction [cystatin C within normal range for age, and UOP > 1 cc/kg/hr], and off significant inotropic support [defined as milrinone >0.3 mcg/kg/min, dopamine >3 mcg/kg/min, dobutamine >3 mcg/kg/min, any combination of these inotropes, or any epinephrine, norepinephrine, phenylephrine or vasopressin)] with a serum lactate <2 mmol/L.
One point will be awarded for each postoperative hour of continued organ dysfunction up to postoperative hour 336 (day 14).
A score of 360 will be assigned if organ failure is not resolved by postoperative day 14, or if the patient requires mechanical circulatory support or experiences mortality.
This variable has been chosen to allow for recognition of early drug effects, and those which might be delayed beyond the immediate postoperative period.
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14 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Myocardial Injury
Periodo de tiempo: 7 days
|
determined by elevated serum cardiac troponin
|
7 days
|
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Oxidative Stress
Periodo de tiempo: 3 days
|
measured by lipoperoxidation (serum F2 isoprostane)
|
3 days
|
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Inflammatory activation (IL-6 and IL-10)
Periodo de tiempo: 3 days
|
3 days
|
|
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Neurologic IR injury
Periodo de tiempo: 3 days
|
measured by serum activin A concentration
|
3 days
|
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ICU Length of Stay
Periodo de tiempo: 60 days
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60 days
|
|
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Hospital Length of Stay
Periodo de tiempo: 60 days
|
60 days
|
|
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Tei Index (via echocardiogram)
Periodo de tiempo: 60 days
|
the sum of the isovolumic contraction and relaxation times divided by the ejection time
|
60 days
|
|
Ventricular ejection fraction (via echocardiogram)
Periodo de tiempo: 60 days
|
the volumetric fraction of fluid ejected from a chamber with each contraction
|
60 days
|
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Tissue doppler E/E' ratio (via echocardiogram)
Periodo de tiempo: 60 days
|
calculated as E wave divided by e' velocities
|
60 days
|
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Composite outcome for neonatal cardiac surgery
Periodo de tiempo: 60 days
|
(per Graham, EM, et al) - binary variable defined as death, use of mechanical circulatory support, cardiac arrest requiring chest compressions, hepatic injury [2 times the upper limit of normal for AST or ALT], renal injury [Cr >1.5 mg/dL], or lactic acidosis [an increasing lactate >5 mmol/L in the postoperative period]
|
60 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- Zhou L, Sung RY, Li K, Pong NH, Xiang P, Shen J, Ng PC, Chen Y. Cardioprotective effect of dexrazoxane in a rat model of myocardial infarction: anti-apoptosis and promoting angiogenesis. Int J Cardiol. 2011 Oct 20;152(2):196-201. doi: 10.1016/j.ijcard.2010.07.015. Epub 2010 Aug 6.
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- Sanchez-Medina J, Gonzalez-Ramella O, Gallegos-Castorena S. The effect of dexrazoxane for clinical and subclinical cardiotoxicity in children with acute myeloid leukemia. J Pediatr Hematol Oncol. 2010 May;32(4):294-7. doi: 10.1097/MPH.0b013e3181d321b3.
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- Tebbi CK, London WB, Friedman D, Villaluna D, De Alarcon PA, Constine LS, Mendenhall NP, Sposto R, Chauvenet A, Schwartz CL. Dexrazoxane-associated risk for acute myeloid leukemia/myelodysplastic syndrome and other secondary malignancies in pediatric Hodgkin's disease. J Clin Oncol. 2007 Feb 10;25(5):493-500. doi: 10.1200/JCO.2005.02.3879.
- Barry EV, Vrooman LM, Dahlberg SE, Neuberg DS, Asselin BL, Athale UH, Clavell LA, Larsen EC, Moghrabi A, Samson Y, Schorin MA, Cohen HJ, Lipshultz SE, Sallan SE, Silverman LB. Absence of secondary malignant neoplasms in children with high-risk acute lymphoblastic leukemia treated with dexrazoxane. J Clin Oncol. 2008 Mar 1;26(7):1106-11. doi: 10.1200/JCO.2007.12.2481.
- Lipshultz SE, Scully RE, Lipsitz SR, Sallan SE, Silverman LB, Miller TL, Barry EV, Asselin BL, Athale U, Clavell LA, Larsen E, Moghrabi A, Samson Y, Michon B, Schorin MA, Cohen HJ, Neuberg DS, Orav EJ, Colan SD. Assessment of dexrazoxane as a cardioprotectant in doxorubicin-treated children with high-risk acute lymphoblastic leukaemia: long-term follow-up of a prospective, randomised, multicentre trial. Lancet Oncol. 2010 Oct;11(10):950-61. doi: 10.1016/S1470-2045(10)70204-7. Epub 2010 Sep 16.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de abril de 2021
Finalización primaria (Anticipado)
1 de octubre de 2021
Finalización del estudio (Anticipado)
1 de enero de 2022
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2021
Primero enviado que cumplió con los criterios de control de calidad
2 de agosto de 2021
Publicado por primera vez (Actual)
9 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
2 de agosto de 2021
Última verificación
1 de agosto de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Anomalías cardiovasculares
- Anomalías congénitas
- Defectos Cardíacos Congénitos
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes Protectores
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Agentes cardiotónicos
- Dexrazoxano
- Razoxano
Otros números de identificación del estudio
- 2020-02-0075
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .