Statistical analysis
death, cirrhosis, pulmonary edema, infection, metabolic disorders, kidney injury
REGRESSION, INFECTION, CIRRHOSIS, METABOLIC DISORDERS
Analysis comparing the early vs delayed RRT randomized arms (RRT timing) was performed according to the intention-to-treat principle. Giving the negligible number of patients lost of follow-up (11/488 = 2%) [A logistic regression model, with the 90-day mortality as an independent variable, was used to evaluate the interaction term between RRT strategy and groups and to assess the association between death and RRT strategy in each group. Results are expressed as odds ratios (ORs) with 95% confidence intervals (CIs). In the presence of a significant interaction, a multivariate model, stratified by center and adjusted for major prognostic factors (age, SOFA score, immunosuppression, presence of cirrhosis, type of infection, presence of chronic kidney injury), was then performed to confirm the significance of the interaction and to estimate the effect of the timing of RRT in each group.Patient characteristics are described according to group and RRT timing. Categorical variables are expressed as number and percentage and were compared using the Chi square or Fisher’s exact test, as appropriate. Continuous variables are expressed as means ± standard deviation (SD) or medians and interquartiles (Quartile (Q) 1 and Q3), and were compared using analysis of variance (ANOVA) or the Kruskall-Wallis test, as appropriate.Secondary outcomes are described across groups according to the timing of RRT initiation. The proportion of patients with severe metabolic disorders or/and pulmonary edema due to fluid overload in the 7 days after randomization, ICU mortality, hospital mortality and RRT dependence were estimated. The ICU length of stay, number of ICU days free of RRT, variation in creatinine relative to the basal level were recorded for surviving, non-RRT-dependent patients at hospital discharge, as well as the hospital length of stay, and are expressed as medians and interquartile range.Analyses were performed with SAS software, version 9.4 (SAS Institute Inc., Cary, NC). All p-values are two-sided, and the significance level was set at 0.05 for all analyses.