Clinical trial NCT06512623: Cytokine Adsorption During Complex Cardiac Surgery: a Controlled Randomized Trial
Official title: Cytokine Adsorption During Complex Cardiac Surgery: the JACCS Controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-cardiac Surgery
Inflammation
Organ Dysfunction Syndrome
Cardiac Disease
Cardio-Pulmonary Bypass
Keywords: Post-pump syndrom
Cytokine Hemoadsorption
Post-operative organ failure
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 (pregnancy test done as standard of care)
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

Primary outcomes:
measure: SOFA score at 24 hours
timeFrame: Within 24 hours of ICU admission
Secondary outcomes:
measure: ICU and hospital length of stay
timeFrame: At time of hospital discharge, an average 20 days after ICU admission
measure: ICU, hospital, and 28 days (from ICU admission) mortality
timeFrame: At time of hospital discharge, an average 20 days after ICU admission and up to 28 days after ICU admission
measure: Days alive without respiratory support
timeFrame: At day 28 from ICU admission
measure: Days alive without renal replacement therapy
timeFrame: At day 28 from ICU admission
measure: Days alive without vasopressors
timeFrame: At day 28 from ICU admission
measure: SOFA score at 48 hours
timeFrame: Measured between 24 hours and 48 hours after ICU admission
measure: Post-operative complications
timeFrame: At time of ICU discharge, up to 7 days after ICU admission
measure: Cytokines levels
timeFrame: at the end of CPB, at the admission in ICU and 24 hours after ICU admission
Other outcomes:
measure: Device-related complications
timeFrame: During cardiopulmonary bypass
measure: Treatment tolerance
timeFrame: During cardiopulmonary bypass
measure: Safety of intervention
timeFrame: From beginning of cardiopulmonary bypass to 7 days after ICU admission,
measure: Feasibility of intervention
timeFrame: During cardiopulmonary bypass
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: CHUV Centre Hospitalier Universitaire Vaudois (CHUV)
name: Antoine Schneider
role: PRINCIPAL_INVESTIGATOR
References: