Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Cytokine removal in critically ill patients with infective endocarditis

Official title: 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

Run by Insel Gruppe AG, University Hospital Bern · NCT03892174 · Data updated 2026-11-12

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.

More Sepsis trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment54 (estimated)
SponsorInsel Gruppe AG, University Hospital Bern
Academic / other
Drugs / interventionsRituximab, prednisone
Locations1 site (Bern)
StatusRecruiting
StartedNovember 14, 2019
Main results expectedNovember 7, 2024
Study endsDecember 31, 2024
Registry record updatedNovember 12, 2024
Trial IDNCT03892174 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older scheduled for cardiac surgery for infective endocarditis with recent antibiotic therapy.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown that immunomodulation can be beneficial in similar patient populations, suggesting a potential for success in this approach.

Who can join: the full rules

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 it's running

  • Dept of Intensive Care Medicine
    Bern, Switzerland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.