Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome (CATCH)
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|ClinicalTrials.gov Identifier: NCT03523039|
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Device: CytoSorb® Hemoadsorption||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
Hemoadsorption is performed using a CytoSorb® cartridge.
Device: CytoSorb® Hemoadsorption
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.
No Intervention: Control
Post-cardiac arrest management will be conducted as per institutional protocols.
- 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.
- 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
- Vasopressor requirements [ Time Frame: 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
- In-hospital mortality [ Time Frame: Day 14, 28 and 90 after randomization ]All-cause mortality
- Shock reversal [ Time Frame: 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) [ Time Frame: Day 1 to 7 after randomization ]Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
- CRP and Procalcitonin Levels [ Time Frame: Day 1, 2, 3 after randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523039
|Contact: Antoine Schneider, MD, PhDfirstname.lastname@example.org|
|Contact: Mauro Oddo, MD, PD||+4121 314 39 email@example.com|
|Centre Hospitalier Universitaire Vaudois||Not yet recruiting|
|Lausanne, Vaud, Switzerland, 1011|
|Contact: Antoine Schneider, MD, PhD|
|Principal Investigator:||Antoine Schneider, MD, PhD||Centre Hospitalier Universitaire Vaudois|