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.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Endocarditis - Bacterial inflammation of the heart valves
(BASEC)
-Severe heart valve inflammation (endocarditis) that requires surgery -Age > 18 years (BASEC)
Criteri di esclusione
-immunosuppressive therapy/medications -connected to a mechanical heart support system -very limited life expectancy (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Informazioni generali
Inselspital, Bern University Hospital,
0041-31-632;
fabian.gisler@clutterinsel.ch(ICTRP)
Informazioni scientifiche
Inselspital, Bern University Hospital,
0041-31-632;
fabian.gisler@clutterinsel.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
04.09.2019
(BASEC)
ID di studio ICTRP
NCT03892174 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
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)
Titolo pubblico
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) (ICTRP)
Malattie studiate
Endocarditis;Sepsis;Septic Shock (ICTRP)
Intervento studiato
Other: Treatment protocol with adsorption (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Lars Englberger, MD;Joerg C Schefold, MD;Joerg C Schefold, MD, joerg.schefold@insel.ch, 0041-31-632;, Inselspital, Bern University Hospital, (ICTRP)
ID secondari
RECREATE (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03892174 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile