JAMA:碳酸氢钠治疗严重代谢性酸中毒和急性肾损伤

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.重要性：静脉输注碳酸氢钠对严重代谢性酸血症和中度至重度急性肾损伤患者预后的影响尚不明确。

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.目的：确定静脉输注碳酸氢钠是否与严重代谢性酸血症和中度至重度急性肾损伤患者第90天全因死亡率相关。

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.设计、设置和参与者：一项随机、开放标签的临床试验，于2019年10月6日至2023年12月19日在法国43个重症监护病房进行，共纳入640名患者，随访期为90天。最后随访日期为2024年6月17日。研究对象为患有严重代谢性酸血症（定义为pH ≤7.20）和中度至重度急性肾损伤的成年人。

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.干预措施：患者以1:1的比例随机分配，接受静脉输注碳酸氢钠或不接受碳酸氢钠治疗，目标是使动脉pH达到7.30或更高。

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.主要结果和测量指标：主要结果是第90天全因死亡率。次要结果包括第28天和第180天全因死亡率；器官支持治疗、血管加压药或有创机械通气的使用；重症监护病房和住院时间；重症监护病房获得性感染；液体平衡；第7天序贯[脓毒症相关]器官衰竭评估评分（评估和评分6个器官系统的功能，评分范围从0[无功能障碍]到4[功能衰竭]；总分范围从0[正常]到24[最大功能衰竭]）；以及第90天的主要不良肾脏事件。

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.结果：在640名随机分配的患者中，627名被分析（对照组313名，碳酸氢钠组314名）。中位年龄为67岁（四分位距，59-74岁）；碳酸氢钠组314名患者中有194名（62%）为男性，对照组313名中有185名（59%）为男性。在主要分析中，碳酸氢钠组第90天全因死亡率为195/314（62.1%），对照组为193/313（61.7%）（绝对差异，0.4；95%置信区间，-7.2至8.0；P = .91）。第28天或第180天全因死亡率未见组间差异。在18个次要结果中，碳酸氢钠组314名患者中有109名（35%）使用了肾脏替代疗法，对照组313名中有157名（50%）（绝对差异，-15.5；95%置信区间，-23.1至-7.8）。其他次要结果（包括不良事件）未见组间差异。

Conclusions and relevance: For patients with severe metabolic acidemia and moderate to severe acute kidney injury, intravenous sodium bicarbonate did not affect mortality.结论和相关性：对于患有严重代谢性酸血症和中度至重度急性肾损伤的患者，静脉输注碳酸氢钠对死亡率没有影响。