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Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass (CCCC)

This study is currently recruiting participants.
Verified December 2016 by Antoine Schneider, Centre Hospitalier Universitaire Vaudois
Sponsor:
ClinicalTrials.gov Identifier:
NCT02775123
First Posted: May 17, 2016
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Antoine Schneider, Centre Hospitalier Universitaire Vaudois
  Purpose

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.


Condition Intervention Phase
Myocardial Ischemia Heart Valve Diseases Device: Cytosorb Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study

Further study details as provided by Antoine Schneider, Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Change in Cytokine levels [ Time Frame: From Baseline (Preoeratively) to 6hrs post CPB ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775123


Contacts
Contact: Antoine G Schneider, MD PhD antoine.schneider@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Antoine G Schneider, MD PhD       antoine.schneider@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
  More Information

Responsible Party: Antoine Schneider, physician associate, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02775123     History of Changes
Other Study ID Numbers: 2015-00010
First Submitted: April 21, 2016
First Posted: May 17, 2016
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Heart Valve Diseases
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases