Serpa Neto Ary, McNamara Mairead, Cooper Jamie, Fujii Tomoko, Higgins Alisa, Hodgson Carol, Navarra Leanlove, Nichol Alistair, Peake Sandra, Rea-Neto Alvaro, Secombe Paul, See Emily, Taylor Pam, Young Meredith, Zampieri Fernando G, Young Paul, Bellomo Rinaldo, Udy Andrew
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
Department of Intensive Care, Austin Hospital, Melbourne, Australia.
Crit Care Resusc. 2025 May 15;27(2):100108. doi: 10.1016/j.ccrj.2025.100108. eCollection 2025 Jun.
Metabolic acidosis is common in critically ill patients and is associated with increased risk of organ dysfunction, need for renal replacement therapy, and death. Despite its frequency and clinical relevance, the optimal treatment approach remains uncertain. Sodium bicarbonate is often used to correct acidosis, but its risk-benefit profile in this setting is unclear.
To describe the study protocol and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial.
Protocol for an international, multicentre, randomised, double-blind, parallel-group, superiority adaptive clinical trial. Five hundred (n = 500) adults with metabolic acidosis and receiving a continuous infusion of a vasopressor will be randomly assigned to sodium bicarbonate or placebo in a 1:1 ratio. SODa-BIC started recruiting in April 2023. It is anticipated that recruitment will be completed in 2026.
The primary outcome will be major adverse kidney events within 30 days (MAKE30). Secondary and tertiary outcomes include 30- and 90-day mortality, receipt of renal replacement therapy, and vasopressor-free and ICU-free days at day 30. All analyses will be conducted on an intention-to-treat basis.
SODa-BIC will evaluate whether sodium bicarbonate improves clinically meaningful outcomes in critically ill patients with metabolic acidosis. The trial has the potential to inform international practice guidelines and provide robust evidence to guide the treatment of a common and severe condition in the intensive care unit.
Clinicaltrials.gov (NCT05697770).
代谢性酸中毒在重症患者中很常见，与器官功能障碍、需要肾脏替代治疗及死亡风险增加相关。尽管其发生率高且具有临床相关性，但最佳治疗方法仍不确定。碳酸氢钠常用于纠正酸中毒，但其在此情况下的风险效益情况尚不清楚。
描述重症监护病房代谢性酸中毒用碳酸氢钠治疗（SODa-BIC）试验的研究方案和统计分析计划。
设计、设置与参与者：一项国际多中心随机双盲平行组优效性适应性临床试验方案。500名患有代谢性酸中毒且正在接受血管活性药物持续输注的成年人将按1:1比例随机分配至碳酸氢钠组或安慰剂组。SODa-BIC于2023年4月开始招募。预计招募工作将于2026年完成。
主要结局为30天内的主要不良肾脏事件（MAKE30）。次要和三级结局包括30天和90天死亡率、接受肾脏替代治疗情况、第30天时无需血管活性药物及无需入住重症监护病房的天数。所有分析将基于意向性分析进行。
SODa-BIC将评估碳酸氢钠是否能改善患有代谢性酸中毒的重症患者具有临床意义的结局。该试验有可能为国际实践指南提供信息，并提供有力证据以指导重症监护病房中一种常见且严重病症的治疗。
Clinicaltrials.gov（NCT05697770）
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