Removal Of CytoKines With cytoSorbenTs After Inflammatory Response Reaction During Cardiac Surgery

NCT06286280 | Completed DMC

• 2 other identifiers: AZ221/21F/23/22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Detailed knowledge about the association between systemic inflammation and endothelial progenitor cell (EPCs) activation during extracorporeal circulation (ECC) is lacking. This pilot study aims to clarify the relationship between CD34-positive EPCs and cytokine release during ECC using the cytokine adsorber to make a predictive statement regarding the clinical expression of inflammation.

Conditions

Inflammatory Response

Keywords

CD34+ endothelial progenitor cells; systemic inflammation; extracorporeal circulation

Outcome Measures

Primary Outcomes (1)

• correlation of endothelial progenitor cells with cytokine levels with and without adsorber use

  How does the number of EPCs during adsorber use correlate with cytokine levels, and how does the adsorber influence the time course of EPC release (measurement before and after adsorber use)?

  24 hours before until day 7 post-surgery

Secondary Outcomes (6)

• Overall mortality rate

  until day 30 post surgery

• Days on ventilator, vasopressor and renal replacement therapy

  until day 30 post-surgery

• incidence of stroke

  until day 30 post-surgery

• length of ICU and in-hospital stay

  until day 30 post-surgery

• Echocardiographic changes

  24 hours before until day 7 post-surgery

Study Arms (2)

Cytosorb group

EXPERIMENTAL

Use of hemoadsorber for removal of cytokines. Participants undergoing cardiac surgery will be treated using a hemoadsorption device (CytoSorb) within the cardiopulmonary Bypass circuit (=Intervention)

Device: cytokine adsorber (CytoSorb®)

Control group

NO INTERVENTION

Participants undergoing cardiac surgery will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)

Interventions

cytokine adsorber (CytoSorb®) DEVICE

binding of cytokines to the sorbent polystyrene of the adsorber during cardiac surgery with extracorporeal circulation

Cytosorb group

Eligibility Criteria

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

You may qualify if:

• planned cardiac surgical procedure with the use of the cardiopulmonary machine as well as with ECMO use (elective or urgent)
• age at the time of surgery of \>18 years.
• informed consent

You may not qualify if:

• An emergency indication;
• endocarditis, a non-sterile inflammation,
• autoimmune diseases, chronic inflammatory diseases (ankylosing spondylitis, psoriasis, rheumatoid arthritis, chronic inflammatory intestinal diseases), an acquired immune deficit (HIV);
• severe liver dysfunction, hepatitis B/0;
• patients on dialysis;
• Patients with a hematopoietic disorder/tumour disease;
• participation in other interventional trials or studies;
• timely and probable follow-up cannot be guaranteed (e.g. due to long distances between home and study site); a pregnancy that cannot be excluded with certainty (no menopause, no sterilization).

Sponsors & Collaborators

• University of Giessen: lead
• Deutsche Stiftung für Herzforschung: collaborator

Study Sites (1)

Universityhospital Giessen, Department of Cardiovascular Surgery

Giessen, Germany, 35392, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not be informed about group allocation
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-center, two-arm randomized-controlled prospective study

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 27, 2025
• Last Updated: April 6, 2025

Record last verified: 2024-03

Locations

DE (1)