A Phase 1/2 interventional study of Cytosorb in Myocardial Ischemia and Heart Valve Diseases, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-25.
Sponsored by Centre Hospitalier Universitaire Vaudois · Phase 1/2, Interventional, and Prevention
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients planned for elective cardiac surgery requiring CPB and (≥1 among):
Exclusion Criteria:
Conventional cardio-pulmonary bypass
Cytosorb added to cardio-pulmonary bypass
Device: Cytosorb
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
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois