Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) - an Investigator-initiated Prospective Randomized Controlled Clinical Trial Comparing Two Established Clinical Protocols

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as injury-associated immunosuppression (IAI) by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects scheduled for routine cardiac surgery for infectious endocarditis (diagnosed according to the predefined DUKE criteria) with antibiotic therapy for ≤ 14 days.

• Presence of informed consent

• Age ≥18 yrs.

Locations
Other Locations
Switzerland
Dept of Intensive Care Medicine
RECRUITING
Bern
Contact Information
Primary
Joerg C Schefold, MD
joerg.schefold@insel.ch
0041-31-632
Time Frame
Start Date: 2019-11-14
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 54
Treatments
No_intervention: Treatment protocol without adsorption
Active_comparator: Treatment protocol with adsorption
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov