Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT) (LEAT)
The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery.
Objective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine.
Study Population All children < 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of >180 minutes.
Methodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only.
Primary Endpoint:
To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.
Secondary Endpoints:
- Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours
- PELOD-2 score on ICU admission, at 48 hours post ICU admission
- ICU and hospital length of stay
- ICU, hospital, and 28 days mortality
- Mechanical - ventilation (MV) free days at day
- Renal replacement therapy (RRT) free days at day 28
- Vasopressors free days at day 28
- Acute kidney injury
- Bleeding complications
- Post operative liver injury
Data Collection:
Blood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure .
Duration: The study is expected to last 24 months.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sivakumar Sivalingam
- Número de telefone: +6032617 8200
- E-mail: sivakumar@ijn.com.my
Estude backup de contato
- Nome: Irni Yusnida Md Rashid
- Número de telefone: +6032617 8385
- E-mail: irni@ijn.com.my
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Children (<18 years old at study inclusion)
- Undergoing a cardiac surgery with CPB of expected duration > 180min
- Prophylactic application of HA during CPB for suspected SIRS.
Exclusion Criteria:
- Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study
- Off-pump procedure
- Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: Control Group
Participants undergoing cardiac surgery with cardiopulmonary bypass and expected prolonged bypass duration (>180 minutes) will receive standard intraoperative management according to institutional practice versus hemoadsorption device and standard of care.
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Experimental: Hemoadsorption Group
Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition to standard-of-care versus standard of care, integrated into the cardiopulmonary bypass (CPB) circuit during surgery.
The specific cartridge is chosen based on the patient's weight.
The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine.
This treatment starts at the beginning of the bypass and ends when the bypass is completed.
|
Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition standard of care integrated into the cardiopulmonary bypass (CPB) circuit during surgery.
The specific cartridge is chosen based on the patient's weight.
The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine.
This treatment starts at the beginning of the bypass and ends when the bypass is completed.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
Prazo: 24 Months
|
To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure.
Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points.
This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period.
|
24 Months
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IJNREC/812/2025
- IJN Foundation (Número de outro subsídio/financiamento: Institut Jantung Negara Foundation (IJNF))
- Jafron Biomedical (Número de outro subsídio/financiamento: Jafron Biomedical Co., Ltd., China)
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