NCT03685383: CYTER

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

Completed NA Last updated 15 March 2021

What this trial tests

NA trial testing Cytosorb removal column in eCPR in Cardiac Arrest in 41 participants. Completed in 8 December 2020.

Timeline

25 September 2019

Primary endpoint
8 December 2020

8 December 2020

Quick facts

Lead sponsor	University Hospital Freiburg
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	25 September 2019
Primary completion	8 December 2020
Estimated completion	8 December 2020
Sites	1 location across Germany

Drugs / interventions tested

• Cytosorb removal column in eCPR
• standard eCPR (va-ECMO)

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →
• Extracorporeal Circulation — all drugs for Extracorporeal Circulation →
• Extracorporeal Membrane Oxygenation — all drugs for Extracorporeal Membrane Oxygenation →
• Cytokine Storm — all drugs for Cytokine Storm →

Sponsor

University Hospital Freiburg

Who can join

Adults 18 to 80, any sex, with Cardiac Arrest or Extracorporeal Circulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cytokine Storm in COVID-19: The Current Evidence and Treatment Strategies.
   Tang Y, Liu J, Zhang D, Xu Z, et al · · 2020 · cited 743× · PMID 32754163 · DOI 10.3389/fimmu.2020.01708
2. Cytokine adsorption in patients with post-cardiac arrest syndrome after extracorporeal cardiopulmonary resuscitation (CYTER) - A single-centre, open-label, randomised, controlled trial.
   Supady A, Zahn T, Kuhl M, Maier S, et al · · 2022 · cited 28× · PMID 35143902 · DOI 10.1016/j.resuscitation.2022.02.001
3. "Cytokine storm", not only in COVID-19 patients. Mini-review.
   Lukan N. · · 2020 · cited 23× · PMID 33007369 · DOI 10.1016/j.imlet.2020.09.007
4. Molecular dynamics simulation and docking studies reveals inhibition of NF-kB signaling as a promising therapeutic drug target for reduction in cytokines storms.
   Kumar A, Bharadwaj T, Muthuraj L, Kumar J, et al · · 2025 · cited 4× · PMID 40307269 · DOI 10.1038/s41598-024-78411-5