碳酸氢钠治疗重症监护室代谢性酸中毒（SODa-BIC）试验的方案总结和统计分析计划

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE

Critical Care and Resuscitation Pub Date : 2025-05-15 DOI:10.1016/j.ccrj.2025.100108

Ary Serpa Neto MD, MSc, PhD , Mairead McNamara BAppSc, MDietPrac , Jamie Cooper MD , Tomoko Fujii MD, PhD , Alisa Higgins PhD , Carol Hodgson PhD , Leanlove Navarra BSN , Alistair Nichol MD, PhD , Sandra Peake MD, PhD , Alvaro Rea-Neto MD, MSc, PhD , Paul Secombe BMBS(hons) MClinSc, FCICM , Emily See MD , Pam Taylor , Meredith Young MPH , Fernando G. Zampieri MD, PhD , Paul Young PhD, FCICM , Rinaldo Bellomo MD, PhD , Andrew Udy MBChB, PhD , SODa-BIC investigators

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引用次数: 0

摘要

背景：代谢性酸中毒在危重患者中很常见，并与器官功能障碍的风险增加、肾脏替代治疗的需要和死亡相关。尽管其频率和临床相关性，最佳治疗方法仍不确定。碳酸氢钠常用于纠正酸中毒，但其在这种情况下的风险-收益情况尚不清楚。目的介绍碳酸氢钠治疗重症监护病房代谢性酸中毒（SODa-BIC）试验的研究方案和统计分析方案。设计、环境和参与者一项国际、多中心、随机、双盲、平行组、优势适应性临床试验的方案。500名（n = 500）接受持续输注血管加压剂的代谢性酸中毒成人将按1:1的比例随机分配到碳酸氢钠组或安慰剂组。可口可乐bic于2023年4月开始招聘。预计招聘工作将于2026年完成。主要结局指标主要结局指标为30天内主要肾脏不良事件（MAKE30）。二级和三级结局包括30天和90天死亡率、接受肾脏替代治疗、第30天无血管加压剂和无icu天数。所有分析将在意向治疗的基础上进行。结果和结论soda - bic将评估碳酸氢钠是否能改善代谢性酸中毒危重患者的临床有意义的结局。该试验有可能为国际实践指南提供信息，并提供强有力的证据，以指导重症监护病房中常见和严重疾病的治疗。

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Protocol summary and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial

Background

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.

Objective

To describe the study protocol and statistical analysis plan for the sodium bicarbonate for metabolic acidosis in the intensive care unit (SODa-BIC) trial.

Design, setting and participants

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.

Main outcome measures

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.

Results and conclusions

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.

Registration

Clinicaltrials.gov (NCT05697770).

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.