Statistical analyses
SECONDARY, RECRUITMENT
For this pilot study, a convenience sample of 20 patients per arm was arbitrarily decided. The protocol allowed to decrease this sample size to 10 patients per arm for either safety reasons or slow recruitment. Patients with an intervention duration < 12 h were excluded from the efficacy analysis.All data were collected and stored within a secured database. Qualitative variables are expressed as numbers (percentages) and continuous variables as median (interquartile range—IQR). Due to the exploratory character of the study and the small number of patients, we only performed descriptive analyses with simple comparison tests between groups. Comparisons of secondary outcomes were made using Fisher’s exact test or Wilcoxon rank-sum test, as appropriate, and were exploratory. In the efficacy analysis, we considered only cytokines with > 50% of values above detection thresholds at randomization and at 48 h. A two-tailed 