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Trial record 17 of 24 for:    cytosorb

Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation (CYTER)

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ClinicalTrials.gov Identifier: NCT03685383
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Duerschmied, University Hospital Freiburg

Brief Summary:
Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a venoarterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). PCAS is characterised by cytokine storm resulting in vasodilation and membrane leakage, which is poorly controlled and often fatal. Case reports and data from the investigators' single-center registry indicate that cytokine adsorption with the CytoSorb removal column can be safely added to va-ECMO, but its efficacy and safety have not been examined systematically. This pilot study will assign all comers undergoing eCPR to va-ECMO with or without cytokine adsorber in a 1:1 fashion. This will ensure comparability and allow analysing clinical endpoints, but is limited by sample size (according to their experience the investigators expect approximately 20 cases per year). The investigators will however be able to generate important data about safety, secondary endpoints such as Interleukin-6-removal or vasopressor use and low-power data about efficacy concerning the primary endpoint 30-day survival.

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two-groups (treatment vs. control), pseudo-randomized, monocentric, nonblinded
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR Cardiac Arrest

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. survival after 30 days [ Time Frame: 30 days ]
    rate of survival after 30 days after eCPR


Secondary Outcome Measures :
  1. secondary outcome measure: cytokine-clearance [ Time Frame: 72 hours ]
    Interleukin-6 level (patient blood)

  2. secondary outcome measure: vasopressor use [ Time Frame: 72 hours ]
    vasopressor-use (µg/h/kg bodyweight)

  3. secondary outcome measure: fluid substitution [ Time Frame: 72 hours ]
    fluid substitution (ml/h/kg bodyweight)

  4. secondary outcome measure: renal function [ Time Frame: 72 hours ]
    serum creatinin level

  5. 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
Criteria

Inclusion Criteria:

  • All patients admitted to our ICU after successful CPR undergoing eCPR will be included in the trial.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Alexander Supady, Dr. +4976127033322 alexander.supady@universitaets-herzzentrum.de

Sponsors and Collaborators
University Hospital Freiburg
Investigators
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Principal Investigator: Daniel Duerschmied, Prof. Dr. University of Freiburg

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Responsible Party: Daniel Duerschmied, Prof. Dr. (Associate Professor), University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT03685383     History of Changes
Other Study ID Numbers: CYTER_SC_2018
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniel Duerschmied, University Hospital Freiburg:
Extracorporeal Circulation
Extracorporeal Membrane Oxygenation
Cytokine Adsorption
Post-Cardiac Arrest Syndrome
Cardiac Arrest
Cardio-Pulmonary Resuscitation

Additional relevant MeSH terms:
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Syndrome
Heart Arrest
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases