This prospective single-center randomized controlled trial aims at evaluating the safety and feasibility of an hemoadsorption protocol using Jafron HA-60 during cardio-pulmonary bypass in 20 pediatric patients undergoing open-heart surgery.
Cardiopulmonary bypass (CPB) is an extracorporeal system that temporarily takes over the functions of the heart and lungs by diverting blood during cardiac surgery. However, the use of CPB is know to trigger a significant systemic inflammatory response, largely mediated by cytokines. In severe cases, this response may result in vasoplegia, hypotension, and subsequent organ dysfunction. Several pharmacological interventions have been investigated to reduce the incidence and severity of this post-surgical inflammatory response, but results have been very mitagated. Among emerging strategies, the pre-procedural removal of circulating cytokines through hemoadsorption represents a promising approach. In particular the use of a HA-60® cartridge (Jafron Biomedical, Guangdong, China) integrated into the CPB circuit may help attenuate the inflammatory cascade. This pilot study is designed to evaluate the feasibility and safety of implementing an hemoadsorption protocol during cardiopulmonary bypass in a pediatric population. Pediatric patients scheduled for complex cardiac procedures will be enrolled before surgery and randomly assigned in a 1:1 ratio to either receive hemoadsorption therapy with standard care (intervention group) or standard care alone (control group). In the intervention group, an HA-60® hemoadsorption cartridge will be integrated into the CPB circuit during setup and used throughout the duration of the bypass. Four blood samples will be collected : Post-anestesia induction, CPB termination, ICU admission, and 24 hours post ICU admission-to measure cytokine levels. Clinical data, including vital signs, organ support, demographics, and medical history, will be recorded in the electronic medical records.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
The hemoadsorption treatment will be performed during the entire duration of the CPB. The blood flow within the hemoadsorber will be controlled and set to 7% of the theoretical minimal CPB flow which is calculated as 2.5 L/min/1.73m2 of body surface area.
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland
Screened-to-enrolled patients' ratio and number of intervention delivery group
* Screened-to-enrolled patients' ratio ≥ 0.3\* * ≥ 80% of intervention delivery in intervention group (number of patients who received hemoadsorption \> 50% of CPB duration) * Duration of recruitment: no more than 36 months (approximately 0.56 patient per month) * \<5% of study interruptions attribuable to insufficiant resources or logistical constraints \*(Previous pilot studies in intervention contexts report screened-to-enrolled patient ratios of approximately 0.30-0.50; therefore a threshold of ≥ 0.30 has been chosen as a minimal acceptable benchmark for feasibility.)
Time frame: Start CPB, End CPB, 1 Day and aftrer 28 day
Device-related adverse events
Assessed with the occurrence of 4 categories of adverse events in each group: Device-related complications: • Technical failure to perform the treatment: thrombosis of the cartridge, circuit leak or inability to perform the treatment for all CPB duration. Tolerance: * New allergic or anaphylactoid reaction (stage ≥ 2 by H. L. Mueller \[5\]) * New fever (\> 39°C for more than an hour). Bleeding/haematological complications\*: * Intracranial haemorrhages * Need for massive transfusion (\>10mL/kg/h during more than 3 consecutive hours) * Incidence of new thrombocytopenia (mild \<150 G/L, moderate, \<100 G/L severe \< 50 G/L) \*(We will consider separately bleeding/haematological complications occurring during the procedure (from CPB initiation to ICU admission) and those occurring from ICU admission to day 7 or ICU discharge, whichever occurs first.) All other event judged relevant by the investigator (i.e. cardiac arrest). NB: "New" means not present at the time of CPB initiation
Time frame: From beginning of cardiopulmonary bypass to 7 days after ICU admission or ICU discharge wichever occurs first.
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 24 hours
Difference in the PELOD-2 score between before surgery and 24 hours after admission to intensive care. The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction)
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Enrollment
20
Time frame: Measured between post-anestesia induction and 24 hours post ICU-admission
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) worst value
Efficacy measured by the PELOD-2 worst value between admission to intensive care and 24 hours after admission to intensive care. The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction)
Time frame: Within 4 hours of ICU admission
Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score at 48 hours
PELOD-2 difference between groups in the PELOD-2 score measured between 24 hours and 48 hours after ICU admission. The higher the PELOD-2 the highest the probability of death.The PELOD-2 score ranges from a minimum of 0 (indicating no organ dysfunction) to a maximum of 33 (indicating the most severe level of organ dysfunction).
Time frame: Measured between 24 hours and 48 hours after ICU admission
Change in cytokine levels compared to baseline
Relative and absolute change in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (post-anestesia induction).
Time frame: at the end of CPB, at the admission in ICU and 24 hours after ICU admission
ICU and hospital lenght of stay
Lengths of stays, in days
Time frame: At time of hospital discharge, an average 20 days after ICU admission
ICU, hospital, and 28 days (from ICU admission) mortality
All-cause mortality
Time frame: At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission
Days alive without respiratory support
Number of days alive and without mechanical ventilation
Time frame: At day 28 from ICU admission
Days alive without renal replacement therapy
Number of days alive and without renal replacement therapy
Time frame: At day 28 from ICU admission]
Days alive without vasopressors
Number of days alive and without vasopressors
Time frame: At day 28 from ICU admission]
Days alive without ECMO support
Number of days alive and without Extracorporeal membrane oxygenation (ECMO)
Time frame: At day 28 from ICU admission
Post-operative complications
Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, liver injury
Time frame: At time of ICU discharge, up to 7 days after ICU admission