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

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ClinicalTrials.gov Identifier: NCT03523039
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Antoine Schneider, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: CytoSorb® Hemoadsorption Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: Hemoadsorption
Hemoadsorption is performed using a CytoSorb® cartridge.
Device: CytoSorb® Hemoadsorption
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.

No Intervention: Control
Post-cardiac arrest management will be conducted as per institutional protocols.



Primary Outcome Measures :
  1. Change in cytokine levels [ Time Frame: From baseline (randomization) to 72 hours after randomization ]
    Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.

  2. Incidence of Treatment-Emergent Adverse Events [ 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 ]
    Rate of intervention-related complications


Secondary Outcome Measures :
  1. Vasopressor requirements [ Time Frame: From baseline (randomization) to 72 hours after randomization ]
    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

  2. In-hospital mortality [ Time Frame: Day 14, 28 and 90 after randomization ]
    All-cause mortality

  3. Shock reversal [ Time Frame: Within 24 hours from randomization ]
    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

  4. Sequential Organ Failure Assessment Score (SOFA) [ Time Frame: Day 1 to 7 after randomization ]
    Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).

  5. CRP and Procalcitonin Levels [ Time Frame: Day 1, 2, 3 after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Norepinephrine dose > 0.2 µg/kg/min to maintain Mean Arterial Pressure > 60-70 mmHg, for at least one hour
  • Need of any other vasoactive agent (including epinephrine and/or dobutamine)

Exclusion Criteria:

  • Evidence for patient's refusal to participate in clinical trials
  • Non commitment for ongoing medical therapy (imminent withdrawal of care)
  • Non-cardiac causes of CA likely (asphyxia, drowning, hypoxia)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523039


Contacts
Contact: Antoine Schneider, MD, PhD +41795561902 antoine.scheider@chuv.ch
Contact: Mauro Oddo, MD, PD +4121 314 39 23 mauro.oddo@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Antoine Schneider, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Antoine Schneider, MD, PhD Centre Hospitalier Universitaire Vaudois

Responsible Party: Antoine Schneider, Doctor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03523039     History of Changes
Other Study ID Numbers: ID 2018-00421
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Antoine Schneider, Centre Hospitalier Universitaire Vaudois:
Cardiac Arrest
Cytokine Hemoadsorption

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases