Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS)

Purpose: To reanalyze the results of the Balanced Solutions in Intensive Care Study (BaSICS) through hierarchical endpoint analysis with win ratio.Methods: All patients with full data in BaSICS trial were elected for the analysis. BaSICS compared balanced solu-tions (Plasma Lye 148) versus 0.9% saline in critically ill patients requiring fluid challenge. The win ratio was de-fined as a hierarchical endpoint of 90-day mortality, recepit of kidney replacement therapy, hospital length-of -stay (LOS), and intensive care unit (ICU) LOS. Both unstratified and stratified (by admission type: planned admis-sion, unplanned admission with sepsis, and unplanned admission without sepsis) approaches were used. A sub-group analysis was performed in patients with traumatic brain injury.Results: A total of 10,490 patients were included in the analysis, resulting in 27,587,566 unique combinations for unstratified WR. Unstratified Win ratio was 1.02 (95% confidence interval 0.97; 1.07), which was similar to strat-ified WR. No stratum in the stratified analysis resulted in significant results. Subgroup analysis confirmed the possible harm of balanced solutions in traumatic brain injury patients (WR 0.80; 95% confidence interval 0.64; 0.99).Conclusion: In this reanalysis of BaSICS, a win ratio analysis largely replicated the results of the main trial, yielding neutral results except for the subgroup of patients with traumatic brain injury where a signal of harm was found.(c) 2022 Published by Elsevier Inc.