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

NCT03334006 · tracked via the Priya Life Science Germany tracker

Sponsor

RWTH Aachen University

Phase

Phase 2

Started

2017-11-20

Last updated

2026-06-11

Condition(s) studied

PeritonitisSepsisSeptic Shock

Investigational drug(s) / intervention(s)

Pentaglobin®/Standard of Care

Pentaglobin®/Standard of Care: Standard-of-Care treatment + Pentaglobin®

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change in Multiple Organ Failure (MOF) score (measured in lung, heart, kidney, liver, blood) from baseline to day 7 after surgical infectious source control in the context of peritonitis. — 7 days
The MOF score is determined in the morning. The following points are distributed per organ: Normal organ function: 0 points; organ dysfunction: 1 point; single organ failure: 2 points. A score \> 4 in the sum of the 5 organs indicates multiple organ failure. Patients who died before the MOF score are assigned a score of 10 points.

Trial sites (20)

Facility	City	Region	Status
Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin	Vienna	Austria	Recruiting
Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin	Tübingen	Baden-Wurttemberg	Terminated
Universitätsklinikum Regensburg, Klinik für Anästhesiologie	Regensburg	Bavaria	Recruiting
Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin	Essen	North Rhine-Westphalia	Recruiting
Charité - Universitätsmedizin Berlin, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin	Berlin	State of Berlin	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
Universitätsklinikum Hamburg-Eppendorf, Klinik für Intensivmedizin	Hamburg	Germany	Recruiting
Medizinische Hochschule Hannover, Zentrum für Anästhesiologie und Intensivmedizin	Hanover	Germany	Withdrawn
Universitätsklinikum Heidelberg, Anästhesiologische Klinik	Heidelberg	Germany	Withdrawn
Klinikum Magdeburg, Klinik für Intensivmedizin	Magdeburg	Germany	Withdrawn
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie	Mainz	Germany	Withdrawn
Klinikum der Universität München, Klinik für Allgemein-, Viszeral- und Transplantationschirurgie	München	Germany	Recruiting
Klinikum Nürnberg, Klinik für Anästhesiologie und operative Intensivmedizin	Nuremberg	Germany	Recruiting
Heinrich-Braun-Klinikum gGmbH, Klinik für Anästhesie, Intensivmedizin, Notfallmedizin und Schmerztherapie	Zwickau	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03334006 on ClinicalTrials.gov ↗ ← All trials in Germany