Status:
RECRUITING
Prospective, Randomized Trial of Personalized Medicine With Pentaglobin® After Surgical Infectious Source Control in Patients With Peritonitis
Lead Sponsor:
RWTH Aachen University
Collaborating Sponsors:
Biotest
Conditions:
Peritonitis
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The patient is diagnosed with secondary or quaternary peritonitis
- 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).
- Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society).
- SOFA Score ≥ 8
- The concentration of IL-6 is ≥ 1000 pg / ml
- Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit
- 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
- Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
- For female patients: The patient is pregnant or breastfeeding.
- The patient is a minor (\< 18 years of age).
- The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²).
- The patient has acute, primarily non-infectious pancreatitis or mediastinitis.
- The patient has a BMI \> 40.
- The patient has any contraindication to study drug.
- The patient has participated in another clinical trial within the last 30 days.
- The patient is in a dependent or employment relationship with the sponsor or investigator.
- The patient is institutionalized by court or government order.
Exclusion
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03334006
Start Date
November 20 2017
End Date
March 1 2028
Last Update
September 15 2025
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Universität Wien, Klinische Abteilung für Allgemeine Anästhesie und Intensivmedizin
Vienna, Austria, 1090
2
Universitätsklinikum Tübingen, Universitätsklinik für Anästhesiologie und Intensivmedizin
Tübingen, Baden-Wurttemberg, Germany, 72076
3
Universitätsklinikum Regensburg, Klinik für Anästhesiologie
Regensburg, Bavaria, Germany, 93053
4
Universitätsklinikum Essen, Klinik für Anästhesiologie und Intensivmedizin
Essen, North Rhine-Westphalia, Germany, 45147