Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial
NCT Number: NCT06512623
Acronym: JACCS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post-cardiac Surgery|Inflammation|Organ Dysfunction Syndrome|Cardiac Disease|Cardio-Pulmonary Bypass
Interventions: DEVICE: Hemoadsoprtion
Sponsor: Centre Hospitalier Universitaire Vaudois
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-12
Locations: Centre Hospitalier Universitaire Vaudois, Lausanne, Vaud, 1011, Switzerland

Summary:
This prospective single-centre randomized controlled trial aims at evaluating the safety and efficacy of hemoadsorption with HA-380® during cardio-pulmonary bypass in 40 patients undergoing complex cardiac surgery.

Primary Outcome Measures: SOFA score at 24 hours, Difference between groups in the SOFA score measured within 24 hours after ICU admission, Within 24 hours of ICU admission
Secondary Outcome Measures: Cytokines levels, Relative and absolute reduction in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (immediately before CPB initiation)., 2 hours after CPB initiation, at ICU admission and 24 hours after ICU admission|ICU and hospital length 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|SOFA score at 48 hours, Sequential Organ Failure Assessment (SOFA) difference between groups in the SOFA score measured between 24hours and 48 hours after ICU admission. The higher the SOFA the highest the probability of death, Measured between 24 hours and 48 hours after ICU admission|Post-operative complications, Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, delirium, liver injury or need for coronary angiography, At time of ICU discharge, up to 7 days after ICU admission
Other Outcome Measures: Device-related complications, Technical failure to perform the treatment (thrombosis of cartridge, circuit leak, inability to perform the treatment for all CPB duration), During cardiopulmonary bypass|Treatment tolerance, New allergic or anaphylactoid reaction (stage ≥ 2 according to H. L. Mueller \[39\]) or new fever (\> 38.5°C), During cardiopulmonary bypass|Safety of intervention, Bleeding and haematological complications Post-operative infections New acute organ rejection, From beginning of cardiopulmonary bypass to 7 days after ICU admission,|Feasibility of intervention, Screened to enrolled patients' ratio, success of intervention delivery in intervention group, duration of recruitment, During cardiopulmonary bypass