Personalized treatment with Pentaglobin® for patients with peritonitis after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of Pentaglobin® as an adjuvant treatment for patients suffering from peritonitis following surgical intervention. It is a prospective, randomized, controlled trial that compares the outcomes of patients receiving standard care with those receiving additional Pentaglobin® treatment. The study will assess improvements in patient outcomes using various scoring systems, including Multiple Organ Failure (MOF) and SOFA scores, and will identify biomarkers to determine which patient subpopulations benefit most from this personalized therapy. The ultimate goal is to lay the groundwork for a future Phase III trial based on the findings of this study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
  Vienna, Austria Recruiting
• 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

Study contacts

• Principal investigator: Gernot Marx, Univ.-Prof. — RWTH Aachen University
• Study coordinator: Center for Translational & Clinical Research (CTC-A)
• Email: PEPPER@ukaachen.de

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.