Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
Hemoadsorption
Hemoadsorption is performed using a CytoSorb® cartridge.
Intervention: CytoSorb® Hemoadsorption (Device)
Control
Post-cardiac arrest management will be conducted as per institutional protocols.
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- CRP and Procalcitonin Levels(Day 1, 2, 3 after randomization)
- In-hospital mortality(Day 14, 28 and 90 after randomization)
- Vasopressor requirements(From baseline (randomization) to 72 hours after randomization)
- Shock reversal(Within 24 hours from randomization)
- Sequential Organ Failure Assessment Score (SOFA)(Day 1 to 7 after randomization)
Investigators
Antoine Schneider
Doctor
Centre Hospitalier Universitaire Vaudois