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

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ClinicalTrials.gov Identifier: NCT03523039
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Antoine Schneider, Centre Hospitalier Universitaire Vaudois

Tracking Information
First Submitted Date  ICMJE April 19, 2018
First Posted Date  ICMJE May 14, 2018
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE February 18, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03523039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2018)
  • 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
  • In-hospital mortality [ Time Frame: Day 14, 28 and 90 after randomization ]
    All-cause mortality
  • 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
  • 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).
  • CRP and Procalcitonin Levels [ Time Frame: Day 1, 2, 3 after randomization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome
Official Title  ICMJE Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Hemoadsorption
    Hemoadsorption is performed using a CytoSorb® cartridge.
    Intervention: Device: CytoSorb® Hemoadsorption
  • No Intervention: Control
    Post-cardiac arrest management will be conducted as per institutional protocols.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antoine Schneider, MD, PhD +41795561902 antoine.scheider@chuv.ch
Contact: Mauro Oddo, MD, PD +4121 314 39 23 mauro.oddo@chuv.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03523039
Other Study ID Numbers  ICMJE ID 2018-00421
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Antoine Schneider, Centre Hospitalier Universitaire Vaudois
Study Sponsor  ICMJE Centre Hospitalier Universitaire Vaudois
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antoine Schneider, MD, PhD Centre Hospitalier Universitaire Vaudois
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP