Protocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial

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dc.contributor.authorSerpa Neto, A.
dc.contributor.authorMcNamara, M.
dc.contributor.authorCooper, J.
dc.contributor.authorFujii, T.
dc.contributor.authorHiggins, A.
dc.contributor.authorHodgson, C.
dc.contributor.authorNavarra, L.
dc.contributor.authorNichol, A.
dc.contributor.authorPeake, S.
dc.contributor.authorRea-Neto, A.
dc.contributor.authorSecombe, P.
dc.contributor.authorSee, E.
dc.contributor.authorTaylor, P.
dc.contributor.authorYoung, M.
dc.contributor.authorZampieri, F.G.
dc.contributor.authorYoung, P.
dc.contributor.authorBellomo, R.
dc.contributor.authorUdy, A.
dc.date.issued2025
dc.description.abstractBackground Metabolic acidosis is common in critically ill patients and is associated with increased risk of organ dysfunction, need for renal replacement therapy, and death. Despite its frequency and clinical relevance, the optimal treatment approach remains uncertain. Sodium bicarbonate is often used to correct acidosis, but its risk–benefit profile in this setting is unclear. Objective To describe the study protocol and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial. Design, setting and participants Protocol for an international, multicentre, randomised, double-blind, parallel-group, superiority adaptive clinical trial. Five hundred (n = 500) adults with metabolic acidosis and receiving a continuous infusion of a vasopressor will be randomly assigned to sodium bicarbonate or placebo in a 1:1 ratio. SODa-BIC started recruiting in April 2023. It is anticipated that recruitment will be completed in 2026. Main outcome measures The primary outcome will be major adverse kidney events within 30 days (MAKE30). Secondary and tertiary outcomes include 30- and 90-day mortality, receipt of renal replacement therapy, and vasopressor-free and ICU-free days at day 30. All analyses will be conducted on an intention-to-treat basis. Results and conclusions SODa-BIC will evaluate whether sodium bicarbonate improves clinically meaningful outcomes in critically ill patients with metabolic acidosis. The trial has the potential to inform international practice guidelines and provide robust evidence to guide the treatment of a common and severe condition in the intensive care unit.
dc.description.statementofresponsibilityAry Serpa Neto, Mairead McNamara, Jamie Cooper, Tomoko Fujii, Alisa Higgins, Carol Hodgson, Leanlove Navarra, Alistair Nichol, Sandra Peake, Alvaro Rea-Neto, Paul Secombe, Emily See, Pam Taylor, Meredith Young, Fernando G. Zampieri, Paul Young, Rinaldo Bellomo, Andrew Udy
dc.identifier.citationCritical Care and Resuscitation, 2025; 27(2):100108-1-100108-9
dc.identifier.doi10.1016/j.ccrj.2025.100108
dc.identifier.issn1441-2772
dc.identifier.issn2652-9335
dc.identifier.orcidPeake, S. [0000-0001-6682-7973]
dc.identifier.urihttps://hdl.handle.net/2440/147916
dc.language.isoen
dc.publisherElsevier B.V.
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT2014960
dc.rights© 2025 Published by Elsevier B.V. on behalf of College of Intensive Care Medicine of Australia and New Zealand. This is an open access article under the CC BY-NCND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
dc.source.urihttps://doi.org/10.1016/j.ccrj.2025.100108
dc.subjectsodium bicarbonate; metabolic acidosis; intensive care unit; shock; vasopressor
dc.titleProtocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial
dc.typeJournal article
pubs.publication-statusPublished

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