Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Oct 29:e2520231.
doi: 10.1001/jama.2025.20231. Online ahead of print.

Sodium Bicarbonate for Severe Metabolic Acidemia and Acute Kidney Injury: The BICARICU-2 Randomized Clinical Trial

Boris Jung  1 , Mathieu Jabaudon  2   3 , Audrey De Jong  4   5 , Laurent Bitker  6   7 , Jules Audard  8   9 , Kada Klouche  1 , Benjamine Sarton  10   11 , Christophe Guitton  12 , Sigismond Lasocki  13 , Benjamin Rieu  14 , Emmanuel Canet  15 , Caroline Jeantrelle  16 , Antoine Roquilly  17   18 , Julien Mayaux  19 , Franck Verdonk  20   21 , Julien Pottecher  22 , Martine Ferrandiere  23 , Beatrice Riu  10   11 , Pierre Garcon  24 , Mona Assefi  25   26 , Philippe Detouche  27 , Jean Marie Forel  28   29 , Claire Roger  30 , Jeremy Bourenne  31   32 , Sophie Jacquier  33 , David Bougon  34 , Amelie Rolle  35   36 , Philippe Corne  1 , Nacim Benchabane  1 , Jean Christophe Richard  37   38 , Karim Asehnoune  17 , Gerald Chanques  4   5 , Jean Reignier  15 , Foud Belafia  4   5 , Maxime Fosset  39 , Helena Huguet  40 , Emmanuel Futier  2   3 , Nicolas Molinari  39 , Samir Jaber  4   5 ; BICARICU-2 Study Group
Collaborators, Affiliations

Sodium Bicarbonate for Severe Metabolic Acidemia and Acute Kidney Injury: The BICARICU-2 Randomized Clinical Trial

Boris Jung et al. JAMA. .

Abstract

Importance: The effect of sodium bicarbonate infusion on outcome in patients with severe metabolic acidemia and moderate to severe acute kidney injury is unknown.

Objective: To determine whether sodium bicarbonate infusion is associated with day 90 all-cause mortality in patients with severe metabolic acidemia and moderate to severe acute kidney injury.

Design, setting, and participants: Randomized, open-label, clinical trial conducted with 640 patients in 43 French intensive care units from October 6, 2019, to December 19, 2023, with 90-day follow-up. The last date of follow-up was June 17, 2024. Adults with severe metabolic acidemia (defined as pH ≤7.20) and moderate to severe acute kidney injury were enrolled.

Intervention: Patients were randomized 1:1 to receive either intravenous sodium bicarbonate infusion or no sodium bicarbonate to target an arterial pH of 7.30 or higher.

Main outcomes and measures: The primary outcome was day 90 all-cause mortality. Secondary outcomes included day 28 and day 180 all-cause mortality; use of organ support therapy, vasopressors, or invasive mechanical ventilation; intensive care unit and hospital length of stay; intensive care unit-acquired infections; fluid balance; day-7 Sequential [Sepsis-related] Organ Failure Assessment score (6 organ systems' function is evaluated and scored from 0 [no dysfunction] to 4 [failure]; total score ranges from 0 [normal] to 24 [maximum failure]); and major adverse kidney events on day 90.

Results: Among 640 randomly assigned patients, 627 were analyzed (313 in the control group and 314 in the bicarbonate group). The median age was 67 years (IQR, 59-74 years); 194 of 314 patients (62%) in the bicarbonate group and 185 of 313 controls (59%) were male. In the primary analysis, day 90 all-cause mortality was 195 of 314 patients (62.1%) in the bicarbonate group and 193 of 313 (61.7%) in the control group (absolute difference, 0.4; 95% CI, -7.2 to 8.0; P = .91). There was no evidence of a group effect on day 28 or day 180 all-cause mortality. Among 18 secondary outcomes, kidney replacement therapy was used in 109 of 314 (35%) bicarbonate group patients and 157 of 313 (50%) controls (absolute difference, -15.5; 95% CI, -23.1 to -7.8). No evidence of a group effect was found on other secondary outcomes, including adverse events.

Conclusions and relevance: For patients with severe metabolic acidemia and moderate to severe acute kidney injury, intravenous sodium bicarbonate did not affect mortality.

Trial registration: ClinicalTrials.gov Identifier: NCT04010630.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr De Jong reported consulting fees from Sanofi, Viatris, and Medtronic. Dr Bitker reported reimbursement of travel expenses related to attending scientific meetings from Pfizer. Dr Lasocki reported consulting fees from CSL Vifor and Pharmacosmos and speaking fees from CSL Vifor, Pharmacosmos, Masimo, and Pfizer. Dr Canet reported lecturer and speaker fees, as well as reimbursements of travel and accommodation expenses related to attending scientific meetings, from Gilead, Shionogi, and Sanofi Genzyme. Dr Corne reported reimbursement of travel expenses related to attending scientific meetings from Pfizer. Dr Benchabane reported reimbursement of travel expenses related to attending scientific meetings from AOP. Dr Richard reported reimbursement of travel expenses related to attending scientific meetings from Pfizer. Dr Jaber reported consulting fees from Dräger, Mindray, Medtronic, Baxter, Fresenius Xenios, and Fisher & Paykel. No other disclosures were reported.

Comment in

  • doi: 10.1001/jama.2025.20457

References

    1. Jung B, Martinez M, Claessens YE, et al. ; Société de Réanimation de Langue Française (SRLF); Société Française de Médecine d’Urgence (SFMU) . Diagnosis and management of metabolic acidosis: guidelines from a French expert panel. Ann Intensive Care. 2019;9(1):92. doi: 10.1186/s13613-019-0563-2 - DOI - PMC - PubMed
    1. Jung B, Rimmele T, Le Goff C, et al. ; AzuRea Group . Severe metabolic or mixed acidemia on intensive care unit admission: incidence, prognosis and administration of buffer therapy: a prospective, multiple-center study. Crit Care. 2011;15(5):R238. doi: 10.1186/cc10487 - DOI - PMC - PubMed
    1. Jaber S, Paugam C, Futier E, et al. ; BICAR-ICU Study Group . Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018;392(10141):31-40. doi: 10.1016/S0140-6736(18)31080-8 - DOI - PubMed
    1. Kraut JA, Madias NE. Treatment of acute metabolic acidosis: a pathophysiologic approach. Nat Rev Nephrol. 2012;8(10):589-601. doi: 10.1038/nrneph.2012.186 - DOI - PubMed
    1. Bendiab E, Garnier F, Soler M, et al. ; BICAR-ICU Investigators . Long-term outcome of severe metabolic acidemia in ICU patients: a BICAR-ICU trial post hoc analysis. Crit Care Med. 2023;51(1):e1-e12. doi: 10.1097/CCM.0000000000005706 - DOI - PubMed

Associated data