NCT02775123

Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Ischemia
• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	Cytosorb	A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-05-17
• Last updated: 2018-01-25

Locations

1 site across 1 country: Switzerland