Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass (CCCC)

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Valve Diseases
• Intervention / Treatment: Device: Cytosorb

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Conventional cardio-pulmonary bypass
EXPERIMENTAL: Cytosorb; Cytosorb added to cardio-pulmonary bypass	Device: Cytosorb; A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Cytokine levels	From Baseline (Preoeratively) to 6hrs post CPB

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU length of stay	90 days
Duration of mechanical ventilation	28 days
Change in Cytokine levels	From Baseline (Preoeratively) to 24 hrs post CPB
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
Hospital Length of stay	90 days
In-hospital mortality	90 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): January 1, 2018
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (ESTIMATE): May 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia; Heart Valve Diseases
• Other Study ID Numbers: 2015-00010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO