急诊科糖尿病酮症酸中毒成人患者中平衡晶体液（乳酸林格氏液）与生理盐水的比较（BRISK-ED）：一项试点随机对照试验方案
Balanced crystalloids (RInger's lactate) versus normal Saline in adults with diabetic Ketoacidosis in the Emergency Department (BRISK-ED): a protocol for a pilot randomized controlled trial.
作者信息
Yan Justin W, Slim Ahmed, Van Aarsen Kristine, Choi Yun-Hee, Byrne Christopher, Poonai Naveen, Collins Haley, Clemens Kristin K
机构信息
Division of Emergency Medicine, Department of Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
Lawson Health Research Institute, London Health Sciences Centre, London, ON, Canada.
出版信息
Pilot Feasibility Stud. 2023 Jul 13;9(1):121. doi: 10.1186/s40814-023-01356-5.
BACKGROUND
Current guidelines for diabetic ketoacidosis (DKA) recommend treatment with normal saline (NS). However, NS, with its high chloride concentrations, may worsen acidosis and contribute to a hyperchloremic metabolic acidosis. Alternatives to NS are balanced crystalloids (e.g. Ringer's Lactate [RL]) which have chloride concentrations similar to human plasma; therefore, treatment with balanced crystalloids may lead to faster DKA resolution. A recent systematic review and meta-analysis by Catahay et al. (2022) demonstrated the need for more blinded, high-quality trials comparing NS versus RL in the treatment of DKA.
METHODS
We describe a protocol for BRISK-ED (Balanced crystalloids [RInger's lactate] versus normal Saline in adults with diabetic Ketoacidosis in the Emergency Department). Our study is a single-centre, triple-blind, pilot randomized controlled trial (RCT) of adults (≥ 18 years) with DKA presenting to an academic tertiary care ED in London, Canada. Patients with clinical suspicion for DKA will be screened and those found to not meet DKA criteria or have euglycemic DKA will be excluded. We will aim to recruit 52 patients with DKA and will randomize them 1:1 to receive intravenous RL or NS. The primary feasibility outcome will be recruitment rate, and the primary efficacy outcome will be time elapsed from ED presentation to DKA resolution. Secondary outcomes include time to insulin infusion discontinuation, intensive care unit admission, in-hospital death, and major adverse kidney events within 30 days, defined as a composite of: i) death, ii) new renal replacement therapy, or iii) final serum creatinine ≥ 200% baseline at the earliest of hospital discharge or 30 days after ED presentation. Patients, clinicians, and outcome assessors will be blinded to allocation group. We will follow an intention-to-treat analysis. Gehan-Wilcoxon, Mann-Whitney U, or chi-square tests will be used to compare groups as appropriate.
DISCUSSION
The results of this pilot study will inform the design and feasibility of a full-scale, multicentre RCT to assess fluid choice in adult ED patients with DKA. If proven to demonstrate faster resolution of DKA, administration of balanced crystalloids may replace NS in diabetes treatment guidelines and improve patient and health systems outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov, Registration # NCT04926740; Registered June 15, 2021.
背景
目前糖尿病酮症酸中毒（DKA）的治疗指南推荐使用生理盐水（NS）进行治疗。然而，NS的氯离子浓度较高，可能会加重酸中毒并导致高氯性代谢性酸中毒。NS的替代方案是平衡晶体液（如乳酸林格氏液[RL]），其氯离子浓度与人体血浆相似；因此，使用平衡晶体液进行治疗可能会使DKA更快得到缓解。Catahay等人（2022年）最近的一项系统综述和荟萃分析表明，需要更多采用盲法的高质量试验来比较NS与RL在DKA治疗中的效果。
方法
我们描述了BRISK-ED（急诊科成年糖尿病酮症酸中毒患者使用平衡晶体液[乳酸林格氏液]与生理盐水的对比研究）的方案。我们的研究是一项单中心、三盲、试点随机对照试验（RCT），研究对象为加拿大伦敦一家学术性三级医疗急诊科的成年（≥18岁）DKA患者。对临床怀疑患有DKA的患者进行筛查，不符合DKA标准或患有血糖正常性DKA的患者将被排除。我们的目标是招募52例DKA患者，并将他们按1:1随机分组，分别接受静脉注射RL或NS。主要可行性结果指标将是招募率，主要疗效结果指标将是从急诊科就诊到DKA缓解所经过的时间。次要结果指标包括停止输注胰岛素的时间、入住重症监护病房、院内死亡以及30天内的主要不良肾脏事件，定义为以下情况之一的组合：i）死亡，ii）开始新的肾脏替代治疗，或iii）在出院最早时间或急诊科就诊后30天时，最终血清肌酐≥基线值的200%。患者、临床医生和结果评估人员将对分组情况保持盲态。我们将采用意向性分析。将根据情况使用Gehan-Wilcoxon检验、Mann-Whitney U检验或卡方检验来比较各组。
讨论
这项试点研究的结果将为评估成年急诊科DKA患者液体选择方案的大规模多中心RCT的设计和可行性提供参考。如果证实使用平衡晶体液能使DKA更快缓解，那么在糖尿病治疗指南中，平衡晶体液的使用可能会取代NS，并改善患者和医疗系统的结局。
试验注册
ClinicalTrials.gov，注册号#NCT04926740；于2021年6月15日注册。
Zotero 插件