Here is the design of a clinical trial:

Official Title: Prospective, Randomized Trial of Personalized Medicine with Pentaglobin® After Surgical Infectious Source Control in Patients with Peritonitis

Included conditions:
- Peritonitis
- Sepsis
- Septic Shock

Study Armgroups:
- {'label': 'Control arm', 'type': 'NO_INTERVENTION', 'description': 'Standard of Care treatment'}
- {'label': 'Verum arm', 'type': 'ACTIVE_COMPARATOR', 'description': 'Standard of Care treatment + Pentaglobin®', 'interventionNames': ['Drug: Pentaglobin®/Standard of Care']}

Interventions:
- {'type': 'DRUG', 'name': 'Pentaglobin®/Standard of Care', 'description': 'Standard of Care treatment + Pentaglobin®', 'armGroupLabels': ['Verum arm']}

Primary Outcomes:
- {'measure': '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.', 'description': '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 was obtained are assigned a score of 10 points.', 'timeFrame': '7 days'}

Please estimate the sample size based on the assumption: 
significance level α = 0.05; power = 90%; randomization ratio verum:control 2:1; additional margin of ~13% for drop-outs
Sample size
        The following assumptions are made: significance level Î±â=â0.05; powerâ=â90%; randomization ratio verum:control 2:1; in MOF score 3.0 (verum) vs 3.8 points (control), each with a standard deviation of 1.5 points. A t-test model led to Nâ=â114 in the active treatment group and 57 in the control group. To allow for drop-outs from the PP population, an additional margin of ~â13% is allowed, giving Nâ=â133 in the active-treatment group and 67 in the control group (total 200).