Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

Myocardial Ischemia Clinical Trial

— CCCC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775123
• Other study ID #: 2015-00010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 21, 2016
• Last updated: January 23, 2018
• Start date: May 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Valve Diseases
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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