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Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

NCT02775123 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-25

No results posted yet for this study

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

DEVICE

Cytosorb

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02775123 on ClinicalTrials.gov