Here is the design of a clinical trial:

Official Title: A Multicentre Concealed-Allocation Multi-arms Blinded Randomized Controlled Trial to Identify the Best Sepsis Population for Corticotherapy

Included conditions:
- Sepsis

Study Armgroups:
- {'label': 'Biomarker CIRCI neg: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker CIRCI neg: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker endocan: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker endocan: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker GILZ: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker GILZ: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker CPD: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker CPD: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker Transcriptomic SRS: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker Transcriptomic SRS: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker Endotype B: Corticosteroid arm', 'type': 'EXPERIMENTAL', 'description': 'Hydrocortisone plus fludrocortisone as treatment: hydrocortisone hemisuccinate and 9 alpha fludrocortisone as experimental treatment.', 'interventionNames': ['Drug: Administration procedures']}
- {'label': 'Biomarker Endotype B: Placebo arm', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo: hydrocortisone placebo and 9 alpha fludrocortisone placebo as placebo treatment.', 'interventionNames': ['Drug: Administration procedures']}

Interventions:
- {'type': 'DRUG', 'name': 'Administration procedures', 'description': 'Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours;\n\n9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning.\n\nStudy drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off.', 'armGroupLabels': ['Biomarker CIRCI neg: Corticosteroid arm', 'Biomarker CIRCI neg: Placebo arm', 'Biomarker CPD: Corticosteroid arm', 'Biomarker CPD: Placebo arm', 'Biomarker Endotype B: Corticosteroid arm', 'Biomarker Endotype B: Placebo arm', 'Biomarker GILZ: Corticosteroid arm', 'Biomarker GILZ: Placebo arm', 'Biomarker Transcriptomic SRS: Corticosteroid arm', 'Biomarker Transcriptomic SRS: Placebo arm', 'Biomarker endocan: Corticosteroid arm', 'Biomarker endocan: Placebo arm']}

Primary Outcomes:
- {'measure': '3-month mortality', 'description': "Patient's vital status.", 'timeFrame': 'Daily up to 3 months'}
- {'measure': 'Persistent organ dysfunction', 'description': 'Persistent organ dysfunction (defined as continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors) and with SOFA score ≤6 up to 90 days.', 'timeFrame': 'At baseline, 1 month and 3 months'}

Please estimate the sample size based on the assumption: 
The significance level (alpha) is 0.05, and the power is 80.04% for vasopressor-free days and 80% for 90-day all-cause mortality. The sample size is inflated fourfold to handle potential dropouts, and Bayesian inference will be used for sequential analyses.
Sample size
          Sequential analyses will use the number of vasopressor-free days at day 28 as the measure of efficacy, and the occurrence of severe adverse events within the first 28 days as the measure of toxicity. In a recent study,8 the number of vasopressor-free days at day 28 with HC+FC was 17.1Â±10.8 vs 15.0Â±11.1 in placebos. Thus, a sample of 176Ã2=352 patients achieves 80.04% power to reject the null hypothesis of equal means when the mean difference between arms is 3âdays with SD of 10 days, and with a significant level (alpha) of 0.05 using a two-sample t-test. For interactions to be detected with the same power as the overall effect, sample sizes should be inflated,29 estimated here at a multiple of fourfold; therefore, to handle potential dropouts, a sample was estimated at 1800 patients. Bayesian inference will be used for sequential analyses.
          To detect a 10% absolute risk reduction from 45% to 35% in 90-day all-cause mortality,8 a sample size of 373 evaluable patients per arm (thus a total of 746 patients) is required to reach 80% power. The planned sample of 1800 patients will achieve a 99.16% power to reject the null hypothesis of equal mortality when the difference between arms is 10% overall, and with a 5% alpha level. Sample sizes were computed using PASS V.15 software (2017).
          The power to detect this difference within each group of analysis will depend on the prevalence of each biomarker of interest.