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RECRUITINGPhase 2INTERVENTIONAL

Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. The patient is diagnosed with secondary or quaternary peritonitis 2. The time of the surgical infectious source control is within 6 hours of indication (defined as date and time of registration for surgical or minimal invasive procedure). 3. Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society). 4. SOFA Score ≥ 8 5. The concentration of IL-6 is ≥ 1000 pg / ml 6. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit 7. The willing to sign a consent form form has been signed by the patient and / or by his legal representative (such as his spouse, an health care proxy authorized or a legal representative) or by a consultant physician Exclusion criteria 1. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock. 2. For female patients: The patient is pregnant or breastfeeding. 3. The patient is a minor (\< 18 years of age). 4. The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²). 5. The patient has acute, primarily non-infectious pancreatitis or mediastinitis. 6. The patient has a BMI \> 40. 7. The patient has any contraindication to study drug. 8. The patient has participated in another clinical trial within the last 30 days. 9. The patient is in a dependent or employment relationship with the sponsor or investigator. 10. The patient is institutionalized by court or government order. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. The patient is diagnosed with secondary or quaternary peritonitis 2. The time of the surgical infectious source control is within 6 hours of indication (defined as date and time of registration for surgical or minimal invasive procedure). 3. Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society). 4. SOFA Score ≥ 8 5. The concentration of IL-6 is ≥ 1000 pg / ml 6. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit 7. The informed consent form has been signed by the patient and / or by his legal representative (such as his spouse, an health care proxy authorized or a legal representative) or by a consultant physician Exclusion criteria 1. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock. 2. For female patients: The patient is pregnant or breastfeeding. 3. The patient is a minor (\< 18 years of age). 4. The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²). 5. The patient has acute, primarily non-infectious pancreatitis or mediastinitis. 6. The patient has a BMI \> 40. 7. The patient has any contraindication to study drug. 8. The patient has participated in another clinical trial within the last 30 days. 9. The patient is in a dependent or employment relationship with the sponsor or investigator. 10. The patient is institutionalized by court or government order.

Treatments Being Tested

DRUG

Pentaglobin®/Standard of Care

Standard-of-Care treatment + Pentaglobin®

Locations (20)

Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
Vienna, Austria
Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, Germany
Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin
Essen, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin
Berlin, State of Berlin, Germany
Uniklinik RWTH Aachen, Klinik für Operative Intensivmedizin und Intermediate Care
Aachen, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Bochum, Germany
Klinikum Westfalen, Knappschaftskrankenhaus Dortmund, Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie
Dresden, Germany
Universitätsklinikum Düsseldorf, Klinik für Anästhesiologie
Düsseldorf, Germany
Universitätklinikum Frankfurt, Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
Frankfurt, Germany
Universitätsklinikum Freiburg, Klinik für Allgemein- und Viszeralchirurgie
Freiburg im Breisgau, Germany
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin
Hamburg, Germany
Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin
Hanover, Germany
Universitätsklinikum Heidelberg, Anästhesiologische Klinik
Heidelberg, Germany
Klinikum Magdeburg, Klinik für Intensivmedizin
Magdeburg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Mainz, Germany
Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
München, Germany
Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin
Nuremberg, Germany
Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Zwickau, Germany