Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation (CYTER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03685383|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : November 16, 2020
|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)|
|Estimated Enrollment :||20 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|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
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
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
|Contact: Alexander Supady, Dr.||+firstname.lastname@example.org|
|University Clinic Freiburg||Recruiting|
|Freiburg, Germany, 79106|
|Contact: Daniel Duerschmied, Prof. Dr. med. +49-761-27034010 email@example.com|
|Contact: Alexander Supady, Dr. med. MPH +49-761-27034010 firstname.lastname@example.org|
|Principal Investigator:||Daniel Duerschmied, Prof. Dr.||University of Freiburg|