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 can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. The patient is diagnosed with secondary or quaternary peritonitis
âś“. 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).
âś“. 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
âś“. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit
âś“. 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
âś•. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
âś•
What they're measuring
1
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.
Timeframe: 7 days
Trial details
NCT IDNCT03334006
SponsorRWTH Aachen University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-09
Contact for this trial
Center for Translational & Clinical Research (CTC-A)