An interventional study of CytoSorb® Hemoadsorption in Cardiac Arrest, sponsored by Centre Hospitalier Universitaire Vaudois. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment
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.
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.
26 studies on the registry are indexed under Post-Cardiac Arrest Syndrome; 9 are open to participants now.
This study's enrollment of 21 is below the median of 158 across 17 interventional studies indexed under Post-Cardiac Arrest Syndrome.
Browse Post-Cardiac Arrest Syndrome studies →Centre Hospitalier Universitaire Vaudois is the lead sponsor of 203 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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):
Exclusion Criteria:
Hemoadsorption is performed using a CytoSorb® cartridge.
Device: CytoSorb® Hemoadsorption
Post-cardiac arrest management will be conducted as per institutional protocols.
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.
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.
Time frame: From baseline (randomization) to 72 hours after randomization
Incidence of Treatment-Emergent Adverse Events
Rate of intervention-related complications
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
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
Time frame: From baseline (randomization) to 72 hours after randomization
In-hospital mortality
All-cause mortality
Time frame: 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
Time frame: 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).
Time frame: Day 1 to 7 after randomization
CRP and Procalcitonin Levels
Time frame: Day 1, 2, 3 after randomization
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire Vaudois