Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

Phase 1

Completed

• Conditions: Myocardial Ischemia; Heart Valve Diseases
• Interventions: Device: Cytosorb

• Registration Number: NCT02775123
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-21
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytosorb	Cytosorb	Cytosorb added to cardio-pulmonary bypass

Primary Outcome Measures

Name	Time	Method
Change in Cytokine levels	From Baseline (Preoeratively) to 6hrs post CPB

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	90 days
Change in Cytokine levels	From Baseline (Preoeratively) to end of CPB
Change in Coagulation factors serum levels	From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB
Duration of the need for vasopressors	28 days
Duration of mechanical ventilation	28 days
ICU length of stay	90 days
Hospital Length of stay	90 days

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland