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.
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
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).
Parallel
Pentaglobin®/Standard of Care
DrugStandard-of-Care treatment + Pentaglobin®
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.
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.
Death within 28 days
Evaluation of death within 28-days.
Death within 90 days
Evaluation of death within 90-days.
Change in MOF Score from baseline to day 5
Change in MOF Score from baseline to day 5.
Multi-Organ Failure (i.e., > 4 MOF points) on day 7
MOF (i.e., \> 4 MOF points) on day 7.
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RWTH Aachen University
Lead sponsor
Biotest
Collaborator
