Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)
21 de marzo de 2015 actualizado por: Dr. Omer Bar-Yosef, Sheba Medical Center
Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit.
The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year.
The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period.
Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event.
Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound.
In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room.
The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years.
Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
75
Fase
- No aplica
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.
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 día a 7 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Every child entering the PCICU, age < 7 years
- The child will enter arm 1 or 2 if he underwent the event described in section 3.
Hypoxic ischemic event that would render hypothermia treatment is defined as
- During the hospitalization in the PCICU before or after the surgery:
Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl OR Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood pH level of less than 7.1
- During the surgery Near infra red spectroscopy lower than 40 for more than 5 minutes AND Serum lactate levels of more than 90 mg/dl during the event OR The patient is re-connected to cardio-pulmonary bypass machine as a result of the event
- Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3.
Exclusion criteria
- Suspected hypoxic ischemic event as described in the Inclusion Criteria in the 2 weeks prior to the PCICU admission
- Prolonged low cerebral perfusion before the PCICU admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and pH lower than 7.1
- Rejection criteria
- A second resuscitation after the hypoxic ischemic event and before a brain MRI is done
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Whole body hypothermia
Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for whole body hypothermia therapy.
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Whole body hypothermia will be to 33 +/- 1 °C .
Treatment period will be 48 hours with 24 hours warming up period.
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Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Cooling will be to 33 +/- 1 °C .
Treatment period will be 48 hours with 24 hours warming up period.
Otros nombres:
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Comparador de placebos: Whole body normothermia
Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for normothermia therapy.
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Cooling will be to 36-37 °C .
Treatment period will be 72 hrs.
|
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Cooling will be to 33 +/- 1 °C .
Treatment period will be 48 hours with 24 hours warming up period.
Otros nombres:
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Sin intervención: Control
A group of children that underwent a cardiac surgery and was not suspected to have an hypoxic ischemic brain injury.
This group will be undergo the similar biomarkers collection as arm 1 and 2. The information will be used to measure the change in biomarkers between surgeries with no HII to those in arm 1+2.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biomarkers
Periodo de tiempo: 48 hours after the surgery
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Each child will have 4 blood samples for biomarkers including S100B, Glial Fibrillary Acidic Protein and Specific Neuronal Enolase at the following schedule: before the cardiac surgery, within 6 hr after the surgery, 24 and 48 hrs after the surgery
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48 hours after the surgery
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Magnetic Resonance Imaging
Periodo de tiempo: 10 days after
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In arms 1 and 2 an MRI with the sequences of T1, T2, Diffusion Weighted Imaging, Diffuse Tensor Imaging and Magnetic Resonance Spectroscopy
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10 days after
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Neurological Evaluation
Periodo de tiempo: 1 week
|
Neurological assessment will be done prior to the cardiac surgery and and one week (or earlier if the child will be fully recovered and discharged before) using standard neurological evaluation, pediatric stroke outcome measure
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1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Short term neuro-developmental outcome
Periodo de tiempo: 2 months
|
Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
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2 months
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Short term neuro-developmental outcome
Periodo de tiempo: 5 yrs
|
At 2 and 5 yrs after the hypothermia treatment a c.
Vineland adaptive behavior scale (Vineland™-II) will be done
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5 yrs
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Omer B Bar Yosef, MD-PhD, Chain Sheba Medical Ceneter
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
1 de abril de 2015
Finalización primaria (Anticipado)
1 de abril de 2017
Finalización del estudio (Anticipado)
1 de abril de 2020
Fechas de registro del estudio
Enviado por primera vez
17 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
20 de marzo de 2015
Publicado por primera vez (Estimar)
23 de marzo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de marzo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
21 de marzo de 2015
Última verificación
1 de marzo de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Anomalías congénitas
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Signos y Síntomas Respiratorios
- Anomalías cardiovasculares
- Cambios de temperatura corporal
- Isquemia cerebral
- Isquemia
- Lesiones Cerebrales
- Defectos Cardíacos Congénitos
- Hipoxia
- Hipotermia
Otros números de identificación del estudio
- SMC-0616-13
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