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Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)
Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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.
Outros nomes:
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Comparador de Placebo: 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.
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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.
Outros nomes:
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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Biomarkers
Prazo: 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
Prazo: 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
Prazo: 1 week
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Short term neuro-developmental outcome
Prazo: 2 months
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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
Prazo: 5 yrs
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Omer B Bar Yosef, MD-PhD, Chain Sheba Medical Ceneter
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças cardíacas
- Doenças cardiovasculares
- Doenças Vasculares
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Ferimentos e Lesões
- Anomalias congénitas
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Sinais e Sintomas Respiratórios
- Anormalidades cardiovasculares
- Mudanças de temperatura corporal
- Isquemia Cerebral
- Isquemia
- Lesões cerebrais
- Defeitos Cardíacos Congênitos
- Hipóxia
- Hipotermia
Outros números de identificação do estudo
- SMC-0616-13
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