Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 25, 2019

Keywords

ClinConnect Summary

The RECReATE clinical trial is studying a new treatment approach for patients with infectious endocarditis, a serious heart infection that can lead to severe immune issues. This trial aims to see if using a device called a cytokine adsorption filter can help boost the immune system in patients who are undergoing heart surgery for this condition. Researchers believe that many patients with infectious endocarditis experience a weakened immune response, which can lead to longer hospital stays, more infections, and higher risk of death. By improving immune function, they hope to improve patient outcomes.

To participate in this trial, you must be at least 18 years old and scheduled for heart surgery to treat infectious endocarditis, having received antibiotics for 14 days or less. However, there are some exclusions, such as recent use of specific immune-related medications or being in critical condition with only a few days to live. If eligible, participants will receive the standard treatment alongside the cytokine filter and will be monitored throughout the process to evaluate its effects on their immune health. This trial is currently recruiting participants, and your involvement could help advance treatment options for this serious condition.

Gender

ALL

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)