SODa-BIC

SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A multicentre, randomised, double-blind clinical trial

Aim:

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 randomisation.

Rationale:

Metabolic acidosis refers to any process that elevates the concentration of hydrogen ions in the body, and is commonly encountered in critical illness. Lactic acidosis, diabetic ketoacidosis, and hyperchloremic acidosis are major examples seen in the intensive care unit (ICU). Metabolic acidosis may impair cardiac function, and sodium bicarbonate can be used to normalise blood pH. Despite being in common clinical usage, the clinical efficacy of sodium bicarbonate is still uncertain. Previous studies exploring the effects of sodium bicarbonate therapy have been limited and of variable quality.

Study Progress:

Ethics approval was obtained through the Alfred HREC in March 2023. Recruitment has commenced in Australia, New Zealand, Brazil, Oman and Saudi Arabia. A total of 500 patients will be enrolled.

Data Entry Webpage: https://redcap.helix.monash.edu/redcap_v12.4.22/index.php?pid=2094

Trial Registration: ClinicalTrials.gov ID NCT05697770

Funding:

SODa-BIC is funded by the NHMRC through their Clinical Trials and Cohort Studies grant scheme (Grant ID 2014960).

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