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Completed

NCT Number: NCT03523039

Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CytoSorb® Hemoadsorption

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)

Acronym: CATCH

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 14, 2018
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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