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.
Cardiopulmonary bypass (CPB) is an extracorporeal circuit used to divert blood from the heart and lungs and take over their functions during cardiac surgery. Cardiac surgery with CPB can induce a major inflammatory response, largely mediated by cytokines. In the most severe cases, this inflammation can lead to vasoplegia, hypotension and potentially end-organ damage. The investigators hypothesised that the removal of inflammatory mediators (e.g. cytokines) from the blood during CPB could reduce the development of postoperative complications in patients with significant inflammation during cardiac surgery. Patients undergoing complex cardiac surgery will be enrolled preoperatively and randomised 1:1 to receive either the investigational hemoadsorption treatment plus standard care (intervention group) or standard care alone (control group). Patients allocated to the intervention group will have an HA-380® cartridge (Jafron Biomedical, Guangdong, China) inserted into the CPB during circuit set-up. Hemoadsorption treatment will be performed throughout the duration of the CPB procedure. For each patient, 4 blood samples will be taken for cytokine measurements (at the start of CPB, at the end of CPB, at ICU admission and 24 hours later). Data on vital signs, organs support, demographics and medical history will be collected in the electronic medical record.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
The hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min.
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
SOFA score at 24 hours
Difference between groups in the SOFA score measured within 24 hours after ICU admission
Time frame: Within 24 hours of ICU admission
ICU and hospital length 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
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
Time frame: Measured between 24 hours and 48 hours after ICU admission
Post-operative complications
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, delirium, liver injury or need for coronary angiography
Time frame: At time of ICU discharge, up to 7 days after ICU admission
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).
Time frame: at the end of CPB, at the admission in ICU and 24 hours after ICU admission