Here is the design of a clinical trial:

Official Title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study

Included conditions:
- Septic Shock

Study Armgroups:
- {'label': 'Remote ischemic conditioning', 'type': 'EXPERIMENTAL', 'description': 'A brachial cuff is positioned around the arm of the patient. The remote ischemic conditioning consists in alternative inflations and deflations of the brachial cuff.', 'interventionNames': ['Device: Remote Ischemic conditioning']}
- {'label': 'Control group', 'type': 'OTHER', 'description': 'A brachial cuff is positioned around the arm of the patient. No inflation or deflation is made.', 'interventionNames': ['Device: Patients with no remote ischemic conditioning']}

Interventions:
- {'type': 'DEVICE', 'name': 'Remote Ischemic conditioning', 'description': 'A brachial cuff is positioned around the arm of the patient. Four cycles of \\[5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation\\] started as soon as possible after randomization. The intervention is repeated at 12 and 24 hours after inclusion.', 'armGroupLabels': ['Remote ischemic conditioning']}
- {'type': 'DEVICE', 'name': 'Patients with no remote ischemic conditioning', 'description': 'A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.', 'armGroupLabels': ['Control group']}

Primary Outcomes:
- {'measure': 'Average SOFA score (Sequential Organ Failure Assessment)', 'description': 'The SOFA score ranges from 0 to 24 (higher scores indicate more severe organ failure), with 0 to 4 points assigned for each of 6 organ dysfunctions (ie, central nervous system, cardiovascular, respiratory, renal, coagulation, and liver).', 'timeFrame': '96 hours.'}

Please estimate the sample size based on the assumption: 
Power of 90% (β = 10%) and type 1 error at α = 5% (two-tailed). Assumed mean daily SOFA score ranging from 8 to 12 with a standard deviation ranging from 4 to 6. Additional 7% patients to account for potential loss to follow-up and withdrawal of consent.
Sample size
        No a priori evidence suggests the magnitude of the effect of RECO on the severity of MOF in septic shock patients. Under the alternative hypothesis of an expected difference of half the standard deviation (effect size: 0.5) of the mean daily SOFA score of the first 4âdays after inclusion, at least 168 patients have to be enrolled to reject the null hypothesis of a similar mean SOFA score in both arms with a power of 90% (Î²â=â10%) and type 1 error at Î±â=â5% (two-tailed). Even though there is no published data regarding the mean daily SOFA score in patients meeting our eligibility criteria, one can assume a mean value ranging from 8 to 12 with a standard deviation ranging from 4 to 6. Thus, for example, if the standard deviation is found to be 4, then a decrease of 2 or more in the mean daily SOFA score will be needed to reach significance. We planned to recruit an additional 7% patients (nâ=â12) to account for potential loss to follow-up and withdrawal of consent. Thus, the planned sample size is 180 patients (90 patients in each arm). Based on the enrollment capacity of the participating centers, the recruitment is expected to be completed within 18âmonths. The sample size was calculated with the use of nQuery Advisor, version 5.0 (Statistical solution, Cork, Ireland).