Study comparing 2 different treatment protocols for severe inflammation of the heart valves (endocarditis) to clarify whether a blood filter has an impact on the immune system.
Zusammenfassung der Studie
In cases of severe bacterial inflammation of one or more heart valves, in addition to drug therapy with antibiotics, heart surgery is also necessary in severe cases. Such a severe infection/inflammation affects the activity of the immune system. Additionally, during heart surgery, various factors also lead to a generalized inflammatory response that activates the immune system, but through regulatory mechanisms also leads to a reduction/suppression of immune system activity. For some time now, there has been an already approved and frequently used blood filter, which is applied during the operation and is supposed to positively influence the immune system by filtering out unwanted signaling substances. However, there are no studies that have demonstrated a direct effect of this filter on the immune system. Our goal is to observe any effects.
(BASEC)
Untersuchte Intervention
Before the operation, it is decided by lottery which patients will also have the filter used during the operation. The other half of the patients is treated and operated on in exactly the same way, but without this filter.
(BASEC)
Untersuchte Krankheit(en)
Endocarditis - Bacterial inflammation of the heart valves
(BASEC)
-Severe heart valve inflammation (endocarditis) that requires surgery -Age > 18 years (BASEC)
Ausschlusskriterien
-immunosuppressive therapy/medications -connected to a mechanical heart support system -very limited life expectancy (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
nicht verfügbar
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Inselspital, Bern University Hospital,
0041-31-632;
fabian.gisler@clutterinsel.ch(ICTRP)
Wissenschaftliche Auskünfte
Inselspital, Bern University Hospital,
0041-31-632;
fabian.gisler@clutterinsel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
04.09.2019
(BASEC)
ICTRP Studien-ID
NCT03892174 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
nicht verfügbar
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) (ICTRP)
Untersuchte Krankheit(en)
Endocarditis;Sepsis;Septic Shock (ICTRP)
Untersuchte Intervention
Other: Treatment protocol with adsorption (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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) (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay) (ICTRP)
Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or.;Area under the curve of quantitative mHLA-DR expression;Change in inflammatory markers including cytokines (Interleukin (IL)-6, IL-10, C-reactive protein, White blood cell count, multiplex Enzyme linked immunosorbent assay, and inflammatory prohormones);Change in organ dysfunction (Sepsis-related organ failure (SOFA) scores incl. subscores and Simplified acute physiology score (SAPS II scores) daily;Length of ICU and hospital stay (days after surgical intervention).;Cumulative Therapeutic Intervention Scoring System (TISS) points (resource need) until ICU-discharge;Total amount of infused volume/transfusions on ICU;Duration of vasoactive drug therapy;Duration of invasive mechanical ventilation;ICU mortality rate;Hospital mortality rate;28 day mortality rate;90 day mortality rate;Duration of renal replacement therapy (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Lars Englberger, MD;Joerg C Schefold, MD;Joerg C Schefold, MD, joerg.schefold@insel.ch, 0041-31-632;, Inselspital, Bern University Hospital, (ICTRP)
Sekundäre IDs
RECREATE (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03892174 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar