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

NCT03685383 | Completed

• 1 other identifier: CYTER_SC_2018
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Extracorporeal Circulation; Extracorporeal Membrane Oxygenation; Cytokine Adsorption; Post-Cardiac Arrest Syndrome; Cardiac Arrest; Cardio-Pulmonary Resuscitation

Outcome Measures

Primary Outcomes (1)

• survival after 30 days

  rate of survival after 30 days after eCPR

  30 days

Secondary Outcomes (5)

• secondary outcome measure: cytokine-clearance

  72 hours

• secondary outcome measure: vasopressor use

  72 hours

• secondary outcome measure: fluid substitution

  72 hours

• secondary outcome measure: renal function

  72 hours

• secondary outcome measure: serum-lactate

  72 hours

Study Arms (2)

intervention group: eCPR + CytoSorb

EXPERIMENTAL

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

control group: eCPR - CytoSorb

ACTIVE COMPARATOR

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)

Interventions

Cytosorb removal column in eCPR DEVICE

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.

intervention group: eCPR + CytoSorb

standard eCPR (va-ECMO) DEVICE

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

control group: eCPR - CytoSorb

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

University Clinic Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Related Publications (1)

• Supady A, Zahn T, Kuhl M, Maier S, Benk C, Kaier K, Bottiger BW, Bode C, Lother A, Staudacher DL, Wengenmayer T, Duerschmied D. Cytokine adsorption in patients with post-cardiac arrest syndrome after extracorporeal cardiopulmonary resuscitation (CYTER) - A single-centre, open-label, randomised, controlled trial. Resuscitation. 2022 Apr;173:169-178. doi: 10.1016/j.resuscitation.2022.02.001. Epub 2022 Feb 7.

  PMID: 35143902 DERIVED

MeSH Terms

Conditions

Heart Arrest; Cytokine Release Syndrome; Post-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Vascular Diseases; Postoperative Complications

Study Officials

• Daniel Duerschmied, Prof. Dr.

  University of Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. (Associate Professor)

Model Details: two-groups (treatment vs. control), pseudo-randomized, monocentric, nonblinded

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 26, 2018
• Study Start: September 25, 2019
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)