Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

Study Overview
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Brief Summary
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Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery. Investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF <35%)]. Patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded. Eligible patients will be approached, consented and enrolled in the trial. Patients will then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb (intervention arm). The target population is 30 patients (15 per arm). For this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB. Secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and hospital length of stay as well as in-hospital mortality. Recruitment period should span from May 2016 to April 2017.

Official Title
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Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study

Conditions
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Myocardial Ischemia, Heart Valve Diseases

Intervention / Treatment
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* Device: Cytosorb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients planned for elective cardiac surgery requiring CPB and (≥1 among): Age >75 years' old AND / OR Double valvular replacement AND / OR Complex surgery with expected CPB time >120 min AND / OR Redo cardiac surgery AND / OR Pre-op chronic renal failure (GFR<30 ml/min) AND / OR Chronic heart failure (LVEF <40%) Exclusion Criteria: End stage renal disease (dialysis dependence) Emergency procedure Active infectious endocarditis Off-pump procedure planned Non steroidal anti-inflammatory treatment in the previous 7 days Corticosteroids administration in the previous 7 days No informed consent Enrolment in another conflicting study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Conventional cardio-pulmonary bypass | |
| Experimental: Cytosorb<br>Cytosorb added to cardio-pulmonary bypass | Device: Cytosorb<br>* A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cytokine levels |  | From Baseline (Preoeratively) to 6hrs post CPB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cytokine levels |  | From Baseline (Preoeratively) to 24 hrs post CPB | 
| Change in Cytokine levels |  | From Baseline (Preoeratively) to end of CPB | 
| Change in Coagulation factors serum levels |  | From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB | 
| Duration of the need for vasopressors |  | 28 days | 
| Duration of mechanical ventilation |  | 28 days | 
| ICU length of stay |  | 90 days | 
| Hospital Length of stay |  | 90 days | 
| In-hospital mortality |  | 90 days |