Condition: Peritonitis · Sepsis · Septic Shock · Sponsor: RWTH Aachen University
The aim of this prospective, randomized, controlled trial is to provide evidence for adjuvant IgGAM treatment with regard to 1. Improvement of patient outcomes for peritonitis. Improvement in outcome will be determined by scores such as MOF, SOFA and survival. 2. Identification of biomarkers (including immunoglobulin levels, HLA-DR, NF-kB1 and other immunological biomarkers) to identify patient subpopulations that benefit most from IgGAM treatment. These patients will form the basis for a further randomized, controlled, double-blind Phase III trial (RCT) to demonstrate the benefit of this treatment. 3. In addition, these biomarkers could help to guide a targeted, i.e. "personalized", adjuvant therapy with Pentaglobin® (IgGAM) in the indication of peritonitis.
This description comes directly from the study's public registry record.
Center for Translational & Clinical Research (CTC-A) · PEPPER@ukaachen.de
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| Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin | Vienna, Austria | Recruiting |
| Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin | Tübingen, Baden-Wurttemberg, Germany | Terminated |
| Universitätsklinikum Regensburg, Klinik für Anästhesiologie | Regensburg, Bavaria, Germany | Recruiting |
| Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin | Essen, North Rhine-Westphalia, Germany | Recruiting |
| Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin | Berlin, State of Berlin, Germany | Recruiting |
| Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care | Aachen, Germany | Recruiting |
| Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie | Bochum, Germany | Recruiting |
| Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie | Dortmund, Germany | Terminated |
| Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie | Dresden, Germany | Withdrawn |
| Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie | Düsseldorf, Germany | Withdrawn |
| Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie | Frankfurt, Germany | Recruiting |
| Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie | Freiburg im Breisgau, Germany | Recruiting |
+ 8 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03334006