NCT03892174 Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)
| NCT ID | NCT03892174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Endocarditis |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2019-11-14 |
| Primary Completion | 2024-11-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2019-11-14 with a primary completion date of 2024-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Previous treatment (last 6 months) with immunologically-active biologicals or specific immunomodulatory drugs (e.g. Rituximab) * high-dose chronic (i.e. before onset of infectious endocarditis) steroid medication with prednisone equivalent of \>30 mg/d * Patients on Extracorporeal membrane oxygenation (ECMO), or any other (pre-operative) cardiac assist device * Moribund patient (life expectancy \<14 days)
Contact & Investigator
Lars Englberger, MD
STUDY DIRECTOR
Inselspital, Bern University Hospital
Frequently Asked Questions
Who can join the NCT03892174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endocarditis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03892174 currently recruiting?
Yes, NCT03892174 is actively recruiting participants. Contact the research team at joerg.schefold@insel.ch for enrollment information.
Where is the NCT03892174 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT03892174 clinical trial?
NCT03892174 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Lars Englberger, MD at Inselspital, Bern University Hospital. The trial plans to enroll 54 participants.