Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial. Serpa Neto, A., Fujii, T., McNamara, M., Moore, J., Young, P. J., Peake, S., Bailey, M., Hodgson, C., Higgins, A. M., See, E. J., Secombe, P., Campbell, L., Young, M., Maeda, M., Pilcher, D., Nichol, A., Deane, A., Licari, E., White, K., French, C., Shehabi, Y., Cross, A., Maiden, M., Kadam, U., El Khawas, K., Cooper, J., Bellomo, R., & Udy, A. Critical Care Medicine, 51(11):e221–e233, November, 2023.
doi  abstract   bibtex   
OBJECTIVES: To identify the best population, design of the intervention, and to assess between-group biochemical separation, in preparation for a future phase III trial. DESIGN: Investigator-initiated, parallel-group, pilot randomized double-blind trial. SETTING: Eight ICUs in Australia, New Zealand, and Japan, with participants recruited from April 2021 to August 2022. PATIENTS: Thirty patients greater than or equal to 18 years, within 48 hours of admission to the ICU, receiving a vasopressor, and with metabolic acidosis (pH \textless 7.30, base excess [BE] \textless -4 mEq/L, and Pa co2 \textless 45 mm Hg). INTERVENTIONS: Sodium bicarbonate or placebo (5% dextrose). MEASUREMENTS AND MAIN RESULT: The primary feasibility aim was to assess eligibility, recruitment rate, protocol compliance, and acid-base group separation. The primary clinical outcome was the number of hours alive and free of vasopressors on day 7. The recruitment rate and the enrollment-to-screening ratio were 1.9 patients per month and 0.13 patients, respectively. Time until BE correction (median difference, -45.86 [95% CI, -63.11 to -28.61] hr; p \textless 0.001) and pH correction (median difference, -10.69 [95% CI, -19.16 to -2.22] hr; p = 0.020) were shorter in the sodium bicarbonate group, and mean bicarbonate levels in the first 24 hours were higher (median difference, 6.50 [95% CI, 4.18 to 8.82] mmol/L; p \textless 0.001). Seven days after randomization, patients in the sodium bicarbonate and placebo group had a median of 132.2 (85.6-139.1) and 97.1 (69.3-132.4) hours alive and free of vasopressor, respectively (median difference, 35.07 [95% CI, -9.14 to 79.28]; p = 0.131). Recurrence of metabolic acidosis in the first 7 days of follow-up was lower in the sodium bicarbonate group (3 [20.0%] vs. 15 [100.0%]; p \textless 0.001). No adverse events were reported. CONCLUSIONS: The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.
@article{serpa_neto_sodium_2023,
	title = {Sodium {Bicarbonate} for {Metabolic} {Acidosis} in the {ICU}: {Results} of a {Pilot} {Randomized} {Double}-{Blind} {Clinical} {Trial}},
	volume = {51},
	issn = {1530-0293},
	shorttitle = {Sodium {Bicarbonate} for {Metabolic} {Acidosis} in the {ICU}},
	doi = {10.1097/CCM.0000000000005955},
	abstract = {OBJECTIVES: To identify the best population, design of the intervention, and to assess between-group biochemical separation, in preparation for a future phase III trial.
DESIGN: Investigator-initiated, parallel-group, pilot randomized double-blind trial.
SETTING: Eight ICUs in Australia, New Zealand, and Japan, with participants recruited from April 2021 to August 2022.
PATIENTS: Thirty patients greater than or equal to 18 years, within 48 hours of admission to the ICU, receiving a vasopressor, and with metabolic acidosis (pH {\textless} 7.30, base excess [BE] {\textless} -4 mEq/L, and Pa co2 {\textless} 45 mm Hg).
INTERVENTIONS: Sodium bicarbonate or placebo (5\% dextrose).
MEASUREMENTS AND MAIN RESULT: The primary feasibility aim was to assess eligibility, recruitment rate, protocol compliance, and acid-base group separation. The primary clinical outcome was the number of hours alive and free of vasopressors on day 7. The recruitment rate and the enrollment-to-screening ratio were 1.9 patients per month and 0.13 patients, respectively. Time until BE correction (median difference, -45.86 [95\% CI, -63.11 to -28.61] hr; p {\textless} 0.001) and pH correction (median difference, -10.69 [95\% CI, -19.16 to -2.22] hr; p = 0.020) were shorter in the sodium bicarbonate group, and mean bicarbonate levels in the first 24 hours were higher (median difference, 6.50 [95\% CI, 4.18 to 8.82] mmol/L; p {\textless} 0.001). Seven days after randomization, patients in the sodium bicarbonate and placebo group had a median of 132.2 (85.6-139.1) and 97.1 (69.3-132.4) hours alive and free of vasopressor, respectively (median difference, 35.07 [95\% CI, -9.14 to 79.28]; p = 0.131). Recurrence of metabolic acidosis in the first 7 days of follow-up was lower in the sodium bicarbonate group (3 [20.0\%] vs. 15 [100.0\%]; p {\textless} 0.001). No adverse events were reported.
CONCLUSIONS: The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.},
	language = {eng},
	number = {11},
	journal = {Critical Care Medicine},
	author = {Serpa Neto, Ary and Fujii, Tomoko and McNamara, Mairead and Moore, James and Young, Paul J. and Peake, Sandra and Bailey, Michael and Hodgson, Carol and Higgins, Alisa M. and See, Emily J. and Secombe, Paul and Campbell, Lewis and Young, Meredith and Maeda, Mikihiro and Pilcher, David and Nichol, Alistair and Deane, Adam and Licari, Elisa and White, Kyle and French, Craig and Shehabi, Yahya and Cross, Anthony and Maiden, Matthew and Kadam, Umesh and El Khawas, Khaled and Cooper, Jamie and Bellomo, Rinaldo and Udy, Andrew},
	month = nov,
	year = {2023},
	pmid = {37294139},
	keywords = {Acidosis, Australia, Double-Blind Method, Humans, Intensive Care Units, Pilot Projects, Sodium Bicarbonate},
	pages = {e221--e233},
}
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