Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass (CCCC)
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|ClinicalTrials.gov Identifier: NCT02775123|
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia Heart Valve Diseases||Device: Cytosorb||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study|
|Actual Study Start Date :||May 2016|
|Primary Completion Date :||January 2018|
|Study Completion Date :||January 2018|
No Intervention: Control
Conventional cardio-pulmonary bypass
Cytosorb added to cardio-pulmonary bypass
A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).
- Change in Cytokine levels [ Time Frame: From Baseline (Preoeratively) to 6hrs post CPB ]
- Change in Cytokine levels [ Time Frame: From Baseline (Preoeratively) to 24 hrs post CPB ]
- Change in Cytokine levels [ Time Frame: From Baseline (Preoeratively) to end of CPB ]
- Change in Coagulation factors serum levels [ Time Frame: From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB ]
- Duration of the need for vasopressors [ Time Frame: 28 days ]
- Duration of mechanical ventilation [ Time Frame: 28 days ]
- ICU length of stay [ Time Frame: 90 days ]
- Hospital Length of stay [ Time Frame: 90 days ]
- In-hospital mortality [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775123
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Vaud, Switzerland, 1011|