A secondary analysis of the SODa-BIC randomized clinical trial using multiple hierarchical composite outcomes
In brief
Sodium bicarbonate shows no overall benefit in a 488-patient ICU trial analysis
In this post-hoc analysis, hierarchical outcome rankings found no overall benefit from sodium bicarbonate for critically ill patients with metabolic acidosis, consistent with the original trial. Results differed across subgroups defined by acute kidney injury and acidosis severity, but this exploratory analysis does not establish who benefits; the overall effect remains neutral.
- Journal
- Critical care science (Q2)
- Published
- 28 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Humphrey G M Walker, Alastair Brown, Kyle C White, Mairead McNamara, D Jamie Cooper, Tomoko Fujii, et al.
- PMID
- 42820515
- DOI
- 10.62675/2965-2774.20260279
Why clinicians should know about it
- Picked for Health Informatics (top studies of the week, 4 October 2026): Post‑hoc hierarchical outcome analysis of ICU trial
Abstract
BACKGROUND: The Sodium Bicarbonate for Metabolic Acidosis in the ICU (SODa-BIC) trial assessed the effect of sodium bicarbonate on Major Adverse Kidney Events at 30 days (MAKE30) in critically ill patients with metabolic acidosis. Although the trial demonstrated no significant difference in the primary outcome, the individual components showed differing magnitudes and directions of effect; we undertook an exploratory analysis of the SODa-BIC trial using different hierarchical outcomes to better understand potential treatment effects of sodium bicarbonate. METHODS: Post-hoc analysis of the SODa-BIC trial. All patients included in the SODa-BIC trial were eligible. The primary outcome was a win ratio analysis with a hierarchy consisting of death, requirement for renal replacement therapy, persistent renal dysfunction, and hospital length of stay. Several sensitivity and subgroup analyses were conducted. RESULTS: The primary analysis resulted in 59,250 pairs from 488 patients. Consistent with the SODa-BIC analysis, there was no overall evidence of a treatment effect of sodium bicarbonate, with a win ratio of 0.97 (95%CI 0.79 - 1.19) and a Desirability of Outcome Ranking probability of 0.49 (95%CI 0.45 - 0.54). A majority of pairwise comparisons were resolved by mortality and hospital length of stay. Evidence of significant treatment effect modification was observed across subgroups defined by acute kidney injury and severity of acidemia. CONCLUSION: In this post-hoc analysis of the SODa-BIC trial, the use of hierarchical composite outcomes did not alter the neutral overall interpretation of the original trial. However, this analysis provides additional insight into the relative contribution of individual components of the primary outcome.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.