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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | Rituximab, prednisone |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | November 14, 2019 |
| Main results expected | November 7, 2024 |
| Study ends | December 31, 2024 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT03892174 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
- Study coordinator: Joerg C Schefold, MD
- Email: joerg.schefold@insel.ch
- Phone: 0041-31-632
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Non-invasive hemodynamic guidance for sepsis care on medical wards
This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.
-
Personalized Fluid Resuscitation in the Emergency Department
This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.
-
Discordance between capillary refill time and oxygen use in septic shock
This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.
-
Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock
This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.
-
Cortisol Levels and Mortality in Septic Shock ICU Patients
This study tests whether cortisol levels can predict death or recovery in adults with sepsis or septic shock in the ICU.
-
oXiris hemofilter use for adults with septic shock and kidney failure
This study tests whether using the oXiris hemofilter during continuous dialysis helps adults with septic shock and acute kidney injury survive and stabilize faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.