drugset / Trial / NCT05697770
SODium BICarbonate for Metabolic Acidosis in the ICU
Phase 3
Active not recruiting
500 enrolled
Australian and New Zealand Intensive Care Research Centre
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.
Timeline
- Start
- 2023-04-26
- Primary completion
- 2026-01-08
- Completion
- 2026-07
Publications
- SODa-BIC Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Serpa Neto A, McNamara M, White K, Cooper DJ, Fujii T, Higgins AM, Hodgson CL, Navarra L, Nichol A, Peake S, Rea-Neto A, Secombe P, Osborne F, Burrill H, See E, Young M, Zampieri FG, Plummer M, Christie C, Nunnink L, Mackay J, McGuinness S, Marmol J, Tiruvoipati R, Bailey M, Young PJ, Bellomo R, Udy A. Sodium Bicarbonate for Critically Ill Adults with Metabolic Acidosis and Shock. N Engl J Med. 2026 Jun 12. doi: 10.1056/NEJMoa2600526. Online ahead of print.
- Serpa Neto A, McNamara M, Cooper J, Fujii T, Higgins A, Hodgson C, Navarra L, Nichol A, Peake S, Rea-Neto A, Secombe P, See E, Taylor P, Young M, Zampieri FG, Young P, Bellomo R, Udy A; SODa-BIC investigators. Protocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial. Crit Care Resusc. 2025 May 15;27(2):100108. doi: 10.1016/j.ccrj.2025.100108. eCollection 2025 Jun.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sodium bicarbonate | Diagnostic / imaging agent | — | Other |