Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

NCT ID: NCT02775123

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-01-31

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.

Conditions

Myocardial Ischemia; Heart Valve Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

Conventional cardio-pulmonary bypass

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cytosorb

Cytosorb added to cardio-pulmonary bypass

Group Type: EXPERIMENTAL

Cytosorb

Intervention Type: DEVICE

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

Interventions

Cytosorb

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Antoine Schneider

physician associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 30944029 (View on PubMed)

Other Identifiers

2015-00010

Identifier Type: -

Identifier Source: org_study_id