Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome
- Conditions
- Cardiac Arrest
- Interventions
- Device: CytoSorb® Hemoadsorption
- Registration Number
- NCT03523039
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemoadsorption CytoSorb® Hemoadsorption Hemoadsorption is performed using a CytoSorb® cartridge.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events 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 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 Outcome Measures
Name Time Method CRP and Procalcitonin Levels Day 1, 2, 3 after randomization In-hospital mortality Day 14, 28 and 90 after randomization All-cause mortality
Vasopressor requirements 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
Shock reversal 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) Day 1 to 7 after randomization Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Vaud, Switzerland