Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation (CYTER)
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|ClinicalTrials.gov Identifier: NCT03685383|
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : March 15, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest Extracorporeal Circulation Extracorporeal Membrane Oxygenation Cytokine Storm Cytokine Release Syndrome Post-Cardiac Arrest Syndrome||Device: Cytosorb removal column in eCPR Device: standard eCPR (va-ECMO)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||two-groups (treatment vs. control), pseudo-randomized, monocentric, nonblinded|
|Masking:||None (Open Label)|
|Official Title:||Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation|
|Actual Study Start Date :||September 25, 2019|
|Actual Primary Completion Date :||December 8, 2020|
|Actual Study Completion Date :||December 8, 2020|
Experimental: intervention group: eCPR + CytoSorb
In addition to standard treatment in patients undergoing eCPR in the intervention group the CytoSorb removal column will be added to the ECLS-system (intervention: CytoSorb removal column in eCPR).
Device: Cytosorb removal column in eCPR
In addition to standard treatment in eCPR in the study group a CytoSorb removal column is added to the va-ECMO system for the prevention of post-cardiac arrest syndrome.
Active Comparator: control group: eCPR - CytoSorb
Patients in the control group will receive standard treatment established for eCPR patients on our ICU. This standard treatment includes, among others, targeted temperature management (TTM) for the first 72 hours. For the use of ECLS as well as TTM we are following well established standard operating procedures (control: standard eCPR (va-ECMO)).
Device: standard eCPR (va-ECMO)
Standard treatment in eCPR with a established va-ECMO system.
- survival after 30 days [ Time Frame: 30 days ]rate of survival after 30 days after eCPR
- secondary outcome measure: cytokine-clearance [ Time Frame: 72 hours ]Interleukin-6 level (patient blood)
- secondary outcome measure: vasopressor use [ Time Frame: 72 hours ]vasopressor-use (µg/h/kg bodyweight)
- secondary outcome measure: fluid substitution [ Time Frame: 72 hours ]fluid substitution (ml/h/kg bodyweight)
- secondary outcome measure: renal function [ Time Frame: 72 hours ]serum creatinin level
- secondary outcome measure: serum-lactate [ Time Frame: 72 hours ]serum-lactate level
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- All patients admitted to our ICU after successful CPR undergoing eCPR will be included in the trial.
- The single exclusion criteria for the trial is, if decision has been made before admission to our ICU to terminate treatment within the next 24 hours.
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): NCT03685383
|University Clinic Freiburg|
|Freiburg, Germany, 79106|
|Principal Investigator:||Daniel Duerschmied, Prof. Dr.||University of Freiburg|
|Responsible Party:||Daniel Duerschmied, Prof. Dr. (Associate Professor), University Hospital Freiburg|
|Other Study ID Numbers:||
|First Posted:||September 26, 2018 Key Record Dates|
|Last Update Posted:||March 15, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Extracorporeal Membrane Oxygenation
Post-Cardiac Arrest Syndrome
Post-Cardiac Arrest Syndrome
Cytokine Release Syndrome
Systemic Inflammatory Response Syndrome
Central Nervous System Diseases
Nervous System Diseases