Clinical trial NCT03523039: Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Cytokine Hemoadsorption
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in cytokine levels
timeFrame: From baseline (randomization) to 72 hours after randomization
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 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 outcomes:
measure: Vasopressor requirements
timeFrame: From baseline (randomization) to 72 hours after randomization
measure: In-hospital mortality
timeFrame: Day 14, 28 and 90 after randomization
measure: Shock reversal
timeFrame: Within 24 hours from randomization
measure: Sequential Organ Failure Assessment Score (SOFA)
timeFrame: Day 1 to 7 after randomization
measure: CRP and Procalcitonin Levels
timeFrame: Day 1, 2, 3 after randomization
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Antoine Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: