Cytokine removal in critically ill patients with infective endocarditis
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
This study is testing if a treatment that removes certain immune proteins can help critically ill patients with infective endocarditis recover better after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | Rituximab, prednisone |
| Locations | 1 site (Bern) |
| Trial ID | NCT03892174 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of cytokine removal in patients undergoing cardiac surgery for infective endocarditis. It focuses on patients who have developed a persistent immunological dysfunction known as injury-associated immunosuppression, which can lead to increased complications and mortality. The intervention involves the use of CytoSorb® treatment to modulate the immune response and potentially improve patient outcomes. The study aims to assess the efficacy of this treatment in reversing the immunosuppressive state associated with severe infections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for cardiac surgery for infective endocarditis with recent antibiotic therapy.
Not a fit: Patients who have received immunologically-active treatments or are in a moribund state with a life expectancy of less than 14 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce complications and improve survival rates in critically ill patients with infective endocarditis.
How similar studies have performed: Previous studies have shown that immunomodulation can be beneficial in similar patient populations, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bern
- Dept of Intensive Care Medicine — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Joerg C Schefold, MD
- Email: joerg.schefold@insel.ch
- Phone: 0041-31-632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.