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.
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
Endocarditis - Bacterial inflammation of the heart valves
(BASEC)
-Severe heart valve inflammation (endocarditis) that requires surgery -Age > 18 years (BASEC)
Critères d'exclusion
-immunosuppressive therapy/medications -connected to a mechanical heart support system -very limited life expectancy (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Informations générales
Inselspital, Bern University Hospital,
0041-31-632;
fabian.gisler@clutterinsel.ch(ICTRP)
Informations scientifiques
Inselspital, Bern University Hospital,
0041-31-632;
fabian.gisler@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
04.09.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT03892174 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
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)
Titre public
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) (ICTRP)
Maladie en cours d'investigation
Endocarditis;Sepsis;Septic Shock (ICTRP)
Intervention étudiée
Other: Treatment protocol with adsorption (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Lars Englberger, MD;Joerg C Schefold, MD;Joerg C Schefold, MD, joerg.schefold@insel.ch, 0041-31-632;, Inselspital, Bern University Hospital, (ICTRP)
ID secondaires
RECREATE (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03892174 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible