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

NCT03685383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-03-15

No results posted yet for this study

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.

Conditions

  • Cardiac Arrest
  • Extracorporeal Circulation
  • Extracorporeal Membrane Oxygenation
  • Cytokine Storm
  • Cytokine Release Syndrome
  • Post-Cardiac Arrest Syndrome

Interventions

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.

DEVICE

standard eCPR (va-ECMO)

Standard treatment in eCPR with a established va-ECMO system.

Sponsors & Collaborators

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Daniel Duerschmied, Prof. Dr. · University of Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2020-12-08
Completion
2020-12-08

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03685383 on ClinicalTrials.gov