Statistical analyses
EVLWi
SECONDARY
Assuming a baseline (inclusion) mean EVLWi of 13 mL/kg and standard deviation (SD) of 5 mL/kg [Baseline characteristics are reported as number (%) for categorical variables and median [interquartile range, IQR] for continuous variables. Efficacy endpoints were analyzed according to intention-to-treat principles. Safety endpoints were analyzed for all patients who received at least one assigned-treatment dose.Missing primary endpoints were replaced by imputation values for patients who died or whose conditions no longer warranted the transpulmonary thermodilution system before 7 days; the last thermodilution value was retained for the primary analyses. Primary endpoints were compared between groups using an adjusted analysis of covariance (ANCOVA) of EVLWi at randomization. Results are expressed in terms of adjusted mean change with 95% confidence interval (CI).Three sensitivity analyses were computed: complete case analysis, worst-case analysis or using a different statistical method (Mann–Whitney U test). Prespecified subgroup analyses were conducted according to VV-ECMO or EVLWi > 10 mL/kg at inclusion.Qualitative and quantitative secondary outcome measures were compared between groups using, respectively, Pearson’s Chi-square tests and Analyses were computed with a 2-sided α risk of 5%. All analyses were performed using R software (R Foundation for Statistical Computing, Vienna, Austria), version 4.0.3.