Cardiac Disease, Cardio-Pulmonary Bypass, Inflammation, Organ Dysfunction Syndrome, Post-cardiac Surgery
Conditions
Keywords
Post-pump syndrom, Cytokine Hemoadsorption, Post-operative organ failure
Brief 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.
Detailed description
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.
Interventions
DEVICEHemoadsoprtion
The hemoadsorption treatment will be performed during the entire duration of the CPB. Blood flow within the cartridge is standardized at 250 ml/min.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (≥18 years old at study inclusion) 2. Planned for one of the following cardiac surgical procedures: heart transplantation after L-VAD (left ventricular assist device) implantation, OR surgical repair of a type A aortic dissection, OR urgent (within a few days) or emergent (within 24 hours) procedure for acute infectious endocarditis, OR cardiac surgery likely to require \>180 min CPB time as estimated by the surgical team 3. Signed informed consent
Exclusion criteria
1. Indication to receive hemoadsorption during CPB for drugs removal 2. Women who are pregnant or breastfeeding 3. Previous enrolment into the current study 4. Off-pump procedure 5. Chronic immunosuppression 6. Known allergy to heparin or heparin induced thrombocytopenia 7. Severe thrombopenia (platelets count before surgery \< 20g/L) 8. Patient who does not want to be informed of incidental findings 9. Participation in another study with investigational drug within the 30 days preceding and during the present study 10. Participation in another conflicting research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score at 24 hours | Within 24 hours of ICU admission | Difference between groups in the SOFA score measured within 24 hours after ICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU and hospital length of stay | At time of hospital discharge, an average 20 days after ICU admission | Lengths of stays, in days |
| ICU, hospital, and 28 days (from ICU admission) mortality | At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission | All-cause mortality |
| Days alive without respiratory support | At day 28 from ICU admission | Number of days alive and without mechanical ventilation |
| Days alive without renal replacement therapy | At day 28 from ICU admission | Number of days alive and without renal replacement therapy |
| Days alive without vasopressors | At day 28 from ICU admission | Number of days alive and without vasopressors |
| SOFA score at 48 hours | Measured between 24 hours and 48 hours after ICU admission | 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 |
| Post-operative complications | At time of ICU discharge, up to 7 days after ICU admission | Post-operative Acute Kidney Injury, transfusion of red blood cells, sepsis, delirium, liver injury or need for coronary angiography |
| Cytokines levels | at the end of CPB, at the admission in ICU and 24 hours after ICU admission | Relative and absolute reduction in the plasma levels of cytokines at different timepoints, compared with their levels at baseline (immediately before CPB initiation). |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORAntoine Schneider
CHUV Centre Hospitalier Universitaire Vaudois (CHUV)
Outcome results
None listed