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Background <p>Two randomized trials (BICAR-ICU and BICAR-ICU2) evaluated intravenous sodium bicarbonate therapy in patients with severe metabolic acidemia but yielded inconclusive results. We performed an individual patient data meta-analysis to assess its effects on 90-day mortality and renal replacement therapy (RRT) use, and search for heterogeneity of treatment effects across prespecified subgroups.</p> Methods <p>We performed an individual patient data meta-analysis of the BICAR-ICU and BICAR-ICU2 trials, including adults with severe metabolic acidemia (pH ≤ 7.20). Patients were randomized to receive intravenous sodium bicarbonate titrated to a pH ≥ 7.30 or no sodium bicarbonate. The primary outcome was 90-day mortality. Secondary outcomes included RRT initiation and dialysis-free days. Prespecified subgroup analyses explored treatment-effect heterogeneity by acidemia depth (pH ≤ 7.10 vs. &gt; 7.10), severe acute kidney injury (AKI) status, and serum lactate (&lt; 2mmol/L vs. ≥2mmol/L).</p> Results <p>A total of 1,016 patients was included (509 sodium bicarbonate, 507 control). Sodium bicarbonate therapy did not significantly reduce 90-day mortality compared to control (58.3% vs. 60.6%; risk ratio [RR], 0.96; 95%CI, 0.86–1.07; <i>p</i> = 0.51). However, it significantly reduced RRT initiation (34.8% vs. 50.7%; RR, 0.69; 95%CI, 0.60–0.79; <i>p</i> &lt; 0.001, number needed to treat: 6.3) and increased dialysis-free days (incidence rate ratio, 1.10; 95%CI, 1.06–1.14; <i>p</i> &lt; 0.001). A significant interaction was observed with acidemia depth (p-for-interaction = 0.006): in patients with pH ≤ 7.10, sodium bicarbonate reduced 90-day mortality (RR, 0.80; 95%CI, 0.68–0.93; <i>p</i> = 0.004); no benefit was seen with pH &gt; 7.10 (RR, 1.05; 95%CI, 0.92–1.21; <i>p</i> = 0.47). No significant interactions were observed for severe AKI status (p-for-interaction = 0.11) nor serum lactate (p-for-interaction = 0.22).</p> Conclusions <p>Sodium bicarbonate therapy did not reduce overall 90-day mortality but decreased RRT use and suggested a mortality benefit in patients with the most profound acidemia (pH ≤ 7.10). These findings invite a reconsideration of current paradigms, suggesting timely correction of severe metabolic acidemia to avoid RRT in some patients.</p>

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Sodium bicarbonate therapy in severe metabolic acidemia: an individual patient data meta-analysis of the BICAR-ICU and BICAR-ICU2 trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月19日

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  • Maxime Fosset,
  • Joris Pensier,
  • Matthieu Jabaudon,
  • Laurent Bitker,
  • Audrey De Jong,
  • Gerald Chanques,
  • Helena Huguet,
  • Nicolas Molinari,
  • Samir Jaber,
  • Boris Jung

摘要

Background

Two randomized trials (BICAR-ICU and BICAR-ICU2) evaluated intravenous sodium bicarbonate therapy in patients with severe metabolic acidemia but yielded inconclusive results. We performed an individual patient data meta-analysis to assess its effects on 90-day mortality and renal replacement therapy (RRT) use, and search for heterogeneity of treatment effects across prespecified subgroups.

Methods

We performed an individual patient data meta-analysis of the BICAR-ICU and BICAR-ICU2 trials, including adults with severe metabolic acidemia (pH ≤ 7.20). Patients were randomized to receive intravenous sodium bicarbonate titrated to a pH ≥ 7.30 or no sodium bicarbonate. The primary outcome was 90-day mortality. Secondary outcomes included RRT initiation and dialysis-free days. Prespecified subgroup analyses explored treatment-effect heterogeneity by acidemia depth (pH ≤ 7.10 vs. > 7.10), severe acute kidney injury (AKI) status, and serum lactate (< 2mmol/L vs. ≥2mmol/L).

Results

A total of 1,016 patients was included (509 sodium bicarbonate, 507 control). Sodium bicarbonate therapy did not significantly reduce 90-day mortality compared to control (58.3% vs. 60.6%; risk ratio [RR], 0.96; 95%CI, 0.86–1.07; p = 0.51). However, it significantly reduced RRT initiation (34.8% vs. 50.7%; RR, 0.69; 95%CI, 0.60–0.79; p < 0.001, number needed to treat: 6.3) and increased dialysis-free days (incidence rate ratio, 1.10; 95%CI, 1.06–1.14; p < 0.001). A significant interaction was observed with acidemia depth (p-for-interaction = 0.006): in patients with pH ≤ 7.10, sodium bicarbonate reduced 90-day mortality (RR, 0.80; 95%CI, 0.68–0.93; p = 0.004); no benefit was seen with pH > 7.10 (RR, 1.05; 95%CI, 0.92–1.21; p = 0.47). No significant interactions were observed for severe AKI status (p-for-interaction = 0.11) nor serum lactate (p-for-interaction = 0.22).

Conclusions

Sodium bicarbonate therapy did not reduce overall 90-day mortality but decreased RRT use and suggested a mortality benefit in patients with the most profound acidemia (pH ≤ 7.10). These findings invite a reconsideration of current paradigms, suggesting timely correction of severe metabolic acidemia to avoid RRT in some patients.