Sodium Bicarbonate for Critically Ill Adults with Metabolic Acidosis and Shock.

Sodium bicarbonate is used to correct acidemia, but its benefit in patients with metabolic acidosis who are receiving vasopressors remains uncertain.

碳酸氢钠用于纠正酸血症，但在接受血管加压药物治疗的代谢性酸中毒患者中其益处仍不明确。

Methods

In this pragmatic, adaptive, double-blind, randomized trial, we assigned adults with metabolic acidosis (pH, <7.30; base excess, no more than -4 mmol per liter; and partial pressure of arterial carbon dioxide, ≤45 mm Hg without intubation or ≤50 mm Hg with intubation) who were receiving vasopressors in the intensive care unit (ICU) to receive either sodium bicarbonate or placebo (5% dextrose).

在这项实用的、自适应的、双盲、随机试验中，我们为在重症监护病房（ICU）接受血管加压药物治疗的代谢性酸中毒成人患者（pH值<7.30；基础差额不超过-4毫摩尔/升；动脉二氧化碳分压≤45毫米汞柱（未插管）或≤50毫米汞柱（已插管））分配了碳酸氢钠或安慰剂（5%葡萄糖）。

Sodium bicarbonate or placebo was infused for up to 5 hours, with the infusion rate adjusted for a target pH of at least 7.30 and base excess of at least 0 mmol per liter.

碳酸氢钠或安慰剂被输注长达5小时，输注速率根据目标pH至少为7.30和基础差额至少为0毫摩尔/升进行调整。

The primary outcome was a major adverse kidney event, defined as death, use of renal-replacement therapy, or persistent renal dysfunction, within 30 days.

主要结果是在30天内发生的重大不良肾脏事件，定义为死亡、使用肾脏替代治疗或持续性肾功能障碍。

Results

A total of 500 patients were enrolled in 55 ICUs across seven countries; 245 patients were assigned to receive sodium bicarbonate and 255 to receive placebo.

共有500名患者在七个国家的55个ICU中被纳入研究；245名患者被分配接受碳酸氢钠治疗，255名患者被分配接受安慰剂。

A major adverse kidney event within 30 days occurred in 98 of 244 patients (40.2%) in the sodium bicarbonate group and in 100 of 254 patients (39.4%) in the placebo group (adjusted difference, 1.2 percentage points; 95% confidence interval[CI], -7.1 to 9.4; P = 0.78).

在30天内，碳酸氢钠组的244名患者中有98名（40.2%）发生了重大不良肾脏事件，而安慰剂组的254名患者中有100名（39.4%）发生了重大不良肾脏事件（调整后的差异，1.2个百分点；95%置信区间[CI]，-7.1至9.4；P = 0.78）。

Renal-replacement therapy was used within 30 days in 16.8% of the patients in the sodium bicarbonate group and in 20.9% of those in the placebo group (adjusted difference, -3.9 percentage points; 95% CI, -10.6 to 2.7).

在30天内，碳酸氢钠组的患者中有16.8%使用了肾脏替代治疗，而在安慰剂组的患者中有20.9%使用了肾脏替代治疗（调整后的差异，-3.9个百分点；95% CI，-10.6至2.7）。

In-hospital mortality by day 30 was 25.4% in the sodium bicarbonate group and 24.0% in the placebo group (adjusted difference, 1.8 percentage points; 95% CI, -5.6 to 9.2).

在住院的第30天，碳酸氢钠组的死亡率为25.4%，而安慰剂组为24.0%（调整后的差异为1.8个百分点；95%置信区间为-5.6至9.2）。

Four patients (1.6%) in the sodium bicarbonate group had an adverse effect, as compared with none in the placebo group (P = 0.06).

在碳酸氢钠组中有4名患者（1.6%）出现了不良反应，而安慰剂组中没有（P = 0.06）。

Conclusions

The use of sodium bicarbonate in critically ill patients with metabolic acidosis receiving vasopressors did not lead to a lower risk of major adverse kidney events within 30 days than placebo.

在使用血管加压药物的危重病人中，碳酸氢钠并没有比安慰剂降低30天内主要不良肾脏事件的风险。

(Funded by the National Health and Medical Research Council of Australia; SODa-BIC ClinicalTrials.gov number, NCT05697770.).

该项目由澳大利亚国家健康与医学研究委员会资助；SODa-BIC临床试验注册号为NCT05697770。