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Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome (CATCH)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CytoSorb® Hemoadsorption
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac Arrest, Cytokine Hemoadsorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Adult (≥18 years old) patients admitted to the ICU after CA, at risk of PACS as defined by the presence of at least one of the following characteristics (at any time within 24hrs of CA):

  • Need for a vasoconstrictor (norepinephrine dose > 0.2 µg/kg/min to maintain MAP > 60-70 mmHg, , or equivalent vasoconstrictor agent) for at least one hour
  • Serum lactate level > 6 mmol/l
  • Time to ROSC > 25 minutes

Exclusion Criteria:

  • Evidence for patient's refusal to participate in clinical trials
  • Non commitment for ongoing medical therapy (imminent withdrawal of care)
  • Cardiac arrest caused by hemorrhagic shock
  • Contraindications to therapeutic heparinization
  • Shock of primary cardiac origin (LVEF <20%)
  • Platelet count <20 G/L
  • Deep immunosuppression state, as defined by neutrophils <1 G/L or CD4 <200 /mm3
  • Pregnancy
  • Acute sickle cell crisis
  • Refractory cardiac arrest with ECMO implantation
  • Need for renal replacement therapy at time of randomization
  • Concomitant enrolment in another study
  • Non availability of the research team at time of eligibility at time of randomization

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hemoadsorption

Control

Arm Description

Hemoadsorption is performed using a CytoSorb® cartridge.

Post-cardiac arrest management will be conducted as per institutional protocols.

Outcomes

Primary Outcome Measures

Change in cytokine levels
Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.
Incidence of Treatment-Emergent Adverse Events
Rate of intervention-related complications

Secondary Outcome Measures

Vasopressor requirements
Including the number of patients with a 50% decrease in the baseline vasopressor dose after 6, 12, 24, 36 and 48 hours, and the % of patients requiring a vasopressor dose increase within 24 hours of baseline
In-hospital mortality
All-cause mortality
Shock reversal
Percentage of patients with shock reversal shock reversal being defined in the present study as a norepinephrine dose <0.1μg/kg/min to maintain MAP >60-70 mmHg and a serum lactate level ≤2 mmol/L
Sequential Organ Failure Assessment Score (SOFA)
Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
CRP and Procalcitonin Levels

Full Information

First Posted
April 19, 2018
Last Updated
March 11, 2022
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT03523039
Brief Title
Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome
Acronym
CATCH
Official Title
Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.
Detailed Description
Patients presenting Post-Cardiac Arrest Syndrome (PCAS) in the 24 hours following their admission in Intensive Care Unit will be randomly assigned either to a control group (standard of care) either to a "Hemoadsorption" group. In the latter, the patient will be connected in the 6 hours following randomization to an extracorporeal circuit, in which a Cytosorb ® cartridge will be placed. The circuit will be set up in hemoperfusion mode. The therapy will take place for a minimum of 12 hours and a maximum of 24 hours. Anticoagulation will be achieved using a regional heparin-protamin regimen. Blood samples will be collected at randomization, T1 (6 hours post-randomization), T2 (12 hours after randomization), T3 (24 hours after randomization), T4 (48 hours after randomization) and T5 (48 hours after randomization), to assess change in inflammatory cytokine levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac Arrest, Cytokine Hemoadsorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemoadsorption
Arm Type
Experimental
Arm Description
Hemoadsorption is performed using a CytoSorb® cartridge.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Post-cardiac arrest management will be conducted as per institutional protocols.
Intervention Type
Device
Intervention Name(s)
CytoSorb® Hemoadsorption
Intervention Description
The therapy is initiated within 6 hours from randomization and maintained for a minimum of 12 consecutive hours to a maximum of 24 consecutive hours.
Primary Outcome Measure Information:
Title
Change in cytokine levels
Description
Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.
Time Frame
From baseline (randomization) to 72 hours after randomization
Title
Incidence of Treatment-Emergent Adverse Events
Description
Rate of intervention-related complications
Time Frame
From beginning of hemoadsorption to 24 hours after the end of hemoadsorption, incidence of adverse events such as haemorrhagic complications, catheter-insertion related complications and anaphylactoid reactions
Secondary Outcome Measure Information:
Title
Vasopressor requirements
Description
Including the number of patients with a 50% decrease in the baseline vasopressor dose after 6, 12, 24, 36 and 48 hours, and the % of patients requiring a vasopressor dose increase within 24 hours of baseline
Time Frame
From baseline (randomization) to 72 hours after randomization
Title
In-hospital mortality
Description
All-cause mortality
Time Frame
Day 14, 28 and 90 after randomization
Title
Shock reversal
Description
Percentage of patients with shock reversal shock reversal being defined in the present study as a norepinephrine dose <0.1μg/kg/min to maintain MAP >60-70 mmHg and a serum lactate level ≤2 mmol/L
Time Frame
Within 24 hours from randomization
Title
Sequential Organ Failure Assessment Score (SOFA)
Description
Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
Time Frame
Day 1 to 7 after randomization
Title
CRP and Procalcitonin Levels
Time Frame
Day 1, 2, 3 after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult (≥18 years old) patients admitted to the ICU after CA, at risk of PACS as defined by the presence of at least one of the following characteristics (at any time within 24hrs of CA): Need for a vasoconstrictor (norepinephrine dose > 0.2 µg/kg/min to maintain MAP > 60-70 mmHg, , or equivalent vasoconstrictor agent) for at least one hour Serum lactate level > 6 mmol/l Time to ROSC > 25 minutes Exclusion Criteria: Evidence for patient's refusal to participate in clinical trials Non commitment for ongoing medical therapy (imminent withdrawal of care) Cardiac arrest caused by hemorrhagic shock Contraindications to therapeutic heparinization Shock of primary cardiac origin (LVEF <20%) Platelet count <20 G/L Deep immunosuppression state, as defined by neutrophils <1 G/L or CD4 <200 /mm3 Pregnancy Acute sickle cell crisis Refractory cardiac arrest with ECMO implantation Need for renal replacement therapy at time of randomization Concomitant enrolment in another study Non availability of the research team at time of eligibility at time of randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Schneider, MD, PhD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

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