Study design
RECRUITMENT
The protocol of POINCARE-2 (POids INtensive CARE 2) trial has been extensively detailed elsewhere [Because of (i) the complex design of the intervention (i.e., a strategy involving multiple health professionals and multiple steps of a decisional algorithm over 14 days requiring a learning phase), and (ii) the open-label design; and to address the potentially resulting contamination bias (i.e., delivery of the strategy in patients randomized to the control group), we opted for a cluster-randomized trial over an individual randomized trial. In addition, due to the amount of evidence suggesting the deleterious effect of fluid imbalance on survival and to the relatively easy-to-implement aspect of the strategy in daily ICU practice, we opted for a stepped wedge design to allow each participating ICU to eventually implement the strategy under scrutiny. A stepped wedge trial is a type of cluster-randomized trial where clusters (ICUs) recruit patients both in the control group during the first period (semester) of recruitment and in the strategy group during the last period (semester) of recruitment; and where the switch between control and strategy recruitment is set at a randomly assigned time (wedge).For feasibility purposes, the recruitment period was restricted to 1 year in each ICU. Relying on a previously published design [CONSORT diagram of patient recruitment in the POINCARE-2 trialWe presented the trial design in Fig. 