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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sivakumar Sivalingam
- Numéro de téléphone: +6032617 8200
- E-mail: sivakumar@ijn.com.my
Sauvegarde des contacts de l'étude
- Nom: Irni Yusnida Md Rashid
- Numéro de téléphone: +6032617 8385
- E-mail: irni@ijn.com.my
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 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.
|
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IJNREC/812/2025
- IJN Foundation (Autre subvention/numéro de financement: Institut Jantung Negara Foundation (IJNF))
- Jafron Biomedical (Autre subvention/numéro de financement: Jafron Biomedical Co., Ltd., China)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .