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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoadsorption | Experimental | Cardiopulmonary bypass (CPB) will be conducted as per institutional protocols and an HA-60® cartridge (Jafron Biomedical, Guangdong, China) will be inserted within the circuit for hemoadsorption. |
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| Control | No Intervention | Cardiopulmonary bypass will be conducted as per institutional protocols, without hemoadsorption (standard-of-care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoadsorption | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Screened-to-enrolled patients' ratio and number of intervention delivery group |
| 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:
Bleeding/haematological complications*:
All other event judged relevant by the investigator (i.e. cardiac arrest). NB: "New" means not present at the time of CPB initiation | From beginning of cardiopulmonary bypass to 7 days after ICU admission or ICU discharge wichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Measured between post-anestesia induction and 24 hours post ICU-admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Cristiani | Contact | +41 79 556 84 60 | isabelle.cristiani@chuv.ch | |
| Antoine Schneider, MD-PhD | Contact | antoine.schneider@chuv.ch |
| Name | Affiliation | Role |
|---|---|---|
| Antoine Schneider, MD-PhD | Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018746 | Systemic Inflammatory Response Syndrome |
| D012769 | Shock |
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| 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) | 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). | 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). | 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 | At time of hospital discharge, an average 20 days after ICU admission |
| ICU, hospital, and 28 days (from ICU admission) mortality | All-cause mortality | 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 | At day 28 from ICU admission |
| Days alive without renal replacement therapy | Number of days alive and without renal replacement therapy | At day 28 from ICU admission] |
| Days alive without vasopressors | Number of days alive and without vasopressors | At day 28 from ICU admission] |
| Days alive without ECMO support | Number of days alive and without Extracorporeal membrane oxygenation (ECMO) | At day 28 from ICU admission |
| Post-operative complications | Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, liver injury | At time of ICU discharge, up to 7 days after ICU admission |