Here is the design of a clinical trial:

Official Title: Dosing of Extracorporeal Cytokine Removal In Septic Shock (DECRISS): a Prospective, Randomized, Multicenter Clinical Trial

Included conditions:
- Septic Shock

Study Armgroups:
- {'label': 'Group A', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to standard medical therapy.', 'interventionNames': ['Combination Product: Standard medical therapy']}
- {'label': 'Group B', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 12 hours.', 'interventionNames': ['Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours']}
- {'label': 'Group C', 'type': 'ACTIVE_COMPARATOR', 'description': 'Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 24 hours.', 'interventionNames': ['Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours']}

Interventions:
- {'type': 'COMBINATION_PRODUCT', 'name': 'Standard medical therapy', 'description': 'Standard medical therapy (according to the Surviving Sepsis Campaign) will include standard monitoring (pulseoximetry, 5-lead ECG, continuous invasive blood pressure monitoring, central venous cannulation and 24 with PiCCO-technology. Norepinephrine as a vasopressor and dobutamine - if needed - as an inotrope will be administered by the attending physician.', 'armGroupLabels': ['Group A']}
- {'type': 'DEVICE', 'name': 'Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours', 'description': 'Standard medical therapy, as discussed above will be applied. Furthermore, Cytosorb will be administered as soon as it is possible after randomization but not later than 2 hour (start of the treatment, T0). In a blood pump circuit in pre-haemofilter position, using a kidney replacement device of Fresenius Multifiltrate as a solo therapy or in combination with renal replacement therapy. It will be run in CVVHD, CVVHDF or CVVH mode with a 150 and 200 ml/min blood flow. Anticoagulation will be applied intravenously with heparin, low molecular weight heparin or citrate. The aim of the pump flow rate will be 100-400 mL/min, and the flow rate will be recorded. Possible shock reversal will be assessed by the physician attending. Adsorber cartridges will be changed in every 12 hours. End of the study period (Te): 12 hours after shock reversal, death of the patient, or maximum of five days, whichever happens first.', 'armGroupLabels': ['Group B']}
- {'type': 'DEVICE', 'name': 'Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours', 'description': 'The standard medical therapy and method of Cytosorb treatment as detailed above will be applied. Adsorber cartridges will be changed in every 24 hours.', 'armGroupLabels': ['Group C']}

Primary Outcomes:
- {'measure': 'Shock reversal', 'description': 'Proportion of patients achieving shock reversal, defined as follows:\n\nno need (or minimal need, meaning max. the 10% of the maximum dose) of vasopressore for 3 hours, with haemodynamic measurements, and arterial, central venous blood gas analysis, arterial lactate level measurement, venous and arterial pCO2-gap and O2 saturation measurements to confirm cardiorespiratory stability', 'timeFrame': 'At the time of shock reversal assessed up to 5 days'}
- {'measure': 'Time to shock reversal', 'description': 'The time from the start of the treatment (T0) until shock reversal', 'timeFrame': 'From the start of the treatment until shock reversal assessed up to 5 days'}

Please estimate the sample size based on the assumption: 
The sample size calculation assumes a 20% dropout rate, 80% power, and a 95% significance level.
Sample size calculation
          Based on the previous case series and the ACESS pilot data, the most apparent clinical benefit is expected to be the reduction in norepinephrine requirement; therefore, we chose shock reversal as the most important outcome.24â26 In the ACESS trial, it was found that one single 24-hour treatment resulted in an almost 70% reduction in the required norepinephrine dose. A similar observation was made in a recent case series,24 in which a 50% reduction was found after a 24-hour treatment. Furthermore, in our pilot study, the most profound effect occurred within the first 12 hours of treatment, as far as norepinephrine requirement and PCT-level reduction are concerned.28 Based on these results, it is postulated that cytokine removal may be most effective in the first hours of treatment, therefore, shock reversal could occur faster in group B as compared with group C and faster in both groups as in group A (controls).
          The sample size calculation was based on patient data from the study of Kogelmann et al.25 The time of shock reversal was separately calculated for those in whom the first adsorber was changed after 12 hours (n=3), and for those who received therapy for 24-hours each time (n=17) (48Â±30 hours vs 68Â±21, respectively). In a recent prospective RCT on patients with sepsis and septic shock, vasopressors were weaned in 96Â±40 hours in the control group (n=50).36
          We considered these differences as clinically relevant and not to be overlooked between the three groups. Sample size calculation suggests that 135 patients (1:1:1) will need to be enrolled (45 in each study arm) to confirm or reject the hypothesis for the primary endpoint with a 20% drop-out, 80% power and 95% significance level. Non-responders will be handled as dropouts and will continue to receive SMT.