Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: CytoSorb® Hemoadsorption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemoadsorption<br>Hemoadsorption is performed using a CytoSorb® cartridge. | Device: CytoSorb® Hemoadsorption<br>* 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.<br>|
| No Intervention: Control<br>Post-cardiac arrest management will be conducted as per institutional protocols. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline (randomization) to 72 hours after randomization | 
| Incidence of Treatment-Emergent Adverse Events | Rate of intervention-related complications | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From baseline (randomization) to 72 hours after randomization | 
| In-hospital mortality | All-cause mortality | Day 14, 28 and 90 after randomization | 
| 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 | Within 24 hours from randomization | 
| Sequential Organ Failure Assessment Score (SOFA) | Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome). | Day 1 to 7 after randomization | 
| CRP and Procalcitonin Levels |  | Day 1, 2, 3 after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Arrest, Cytokine Hemoadsorption