Cytokine Clearance With Cytoabsorbant Device During Cardi... | NCT02775123

Studies
Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass

NCT02775123

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Jan 25, 2018Actual

Enrollment

30Actual

Phase

Phase 1Phase 2

Conditions

Myocardial Ischemia
Heart Valve Diseases

Interventions

Cytosorb

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Apr 21, 2016

First Submission Date that Met QC Criteria

May 13, 2016

First Posted Date

May 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2018

Last Update Posted Date

Jan 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Antoine Schneider, physician associate, Centre Hospitalier Universitaire VaudoisPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Conventional cardio-pulmonary bypass
Cytosorb	Experimental	Cytosorb added to cardio-pulmonary bypass	Device: Cytosorb

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytosorb	Device	A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).	Cytosorb

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Vaudois		Lausanne	Canton of Vaud	1011	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30944029	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D017202	Myocardial Ischemia
D006349	Heart Valve Diseases