Clinical trial NCT02775123: Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass
Official title: Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Ischemia
Heart Valve Diseases
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Cytokine levels
timeFrame: From Baseline (Preoeratively) to 6hrs post CPB
Secondary outcomes:
measure: Change in Cytokine levels
timeFrame: From Baseline (Preoeratively) to 24 hrs post CPB
measure: Change in Cytokine levels
timeFrame: From Baseline (Preoeratively) to end of CPB
measure: Change in Coagulation factors serum levels
timeFrame: From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB
measure: Duration of the need for vasopressors
timeFrame: 28 days
measure: Duration of mechanical ventilation
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 90 days
measure: Hospital Length of stay
timeFrame: 90 days
measure: In-hospital mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
References:
citation: Poli EC, Alberio L, Bauer-Doerries A, Marcucci C, Roumy A, Kirsch M, De Stefano E, Liaudet L, Schneider AG. Cytokine clearance with CytoSorb(R) during cardiac surgery: a pilot randomized controlled trial. Crit Care. 2019 Apr 3;23(1):108. doi: 10.1186/s13054-019-2399-4.