NCT02775123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

April 21, 2016

Last Update Submit

January 23, 2018

Conditions

Myocardial IschemiaHeart Valve Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in Cytokine levels

    From Baseline (Preoeratively) to 6hrs post CPB

Secondary Outcomes (8)

  • 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

  • Duration of mechanical ventilation

    28 days

  • +3 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Conventional cardio-pulmonary bypass

Cytosorb

EXPERIMENTAL

Cytosorb added to cardio-pulmonary bypass

Device: Cytosorb

Interventions

CytosorbDEVICE

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

Cytosorb

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30944029DERIVED

MeSH Terms

Conditions

Myocardial IschemiaHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician associate

Study Record Dates

First Submitted

April 21, 2016

First Posted

May 17, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)