Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT)

Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (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:

1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours
2. PELOD-2 score on ICU admission, at 48 hours post ICU admission
3. ICU and hospital length of stay
4. ICU, hospital, and 28 days mortality
5. Mechanical - ventilation (MV) free days at day
6. Renal replacement therapy (RRT) free days at day 28
7. Vasopressors free days at day 28
8. Acute kidney injury
9. Bleeding complications
10. 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.

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