Balanced Multi-electrolyte Solution Versus 0.9% Sodium Chloride as Fluid Therapy for Patients Presenting With Moderate to Severe Diabetic Ketoacidosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 680
- 试验地点
- 21
- 主要终点
- Hospital free days (HFD) up to day-28 after study enrolment
研究概览
简要总结
The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).
详细描述
DKA is a life-threatening complication of diabetes mellitus, described in patients with both type-1 diabetes, and type-2 diabetes(1). Data from the Australian Institute of Health and Welfare suggest that between 2009-10 to 2014-15, there has been a 21% increase in the hospitalisation amongst young people with DKA(2). An interrogation of the Australian and New Zealand Intensive Care Society (ANZICS) Centre for Outcomes Research (CORE) database revealed that the incidence of ICU admission of patients with DKA in Australia and New Zealand increased 5-fold between 2000 and 2013 (0.97/100000, 95%CI 0.84 to1.10) in 2000 to (5.3/100000, 95%CI 4.98to 5.53, (P<0.0001)(3).
Increasing incidences were observed predominantly in rural and metropolitan hospitals (Figure 1), about 88% of the admissions to the ICU were from the ED. The median (IQR) ICU and hospital length of stay were 1.8 (1-2.8) and 4 (2.6-7.4) days respectively. Recent data from the ANZICS-CORE database confirmed the persistent high admission rate of severe DKA to Australian ICUs - 2849 and 2862 admissions in 2019 and 2020.
A major review of DKA management protocols in 2017 concluded that there are major deficiencies in evidence for optimal management of DKA(33). Current practice is guided by weak evidence and consensus opinion.
Studies comparing Plasma-Lyte® 148 vs. 0.9% saline in DKA demonstrate a trend towards a more rapid resolution of acidosis, equivalent glucose control and stable ketones with Plasma-Lyte® 148. In addition, there are trends towards reduced length of ICU and hospital stay with the use of Plasma-Lyte® 148.
Given the clinical uncertainty and substantial variability in practice. there is a scientific, clinical and health economic imperative to conduct a high-fidelity study to provide definitive evidence to inform clinicians regarding the choice of resuscitation fluids for patients with DKA. BEST-DKA will address this critical knowledge gap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids
- •Blood glucose level > 14mmol/L
- •pH < 7.25
- •Serum bicarbonate <15 mmol/L
- •Elevated anion gap > 12mEq/L
- •Ketones positive on finger prick measurements
- •In the judgement of the treating clinician critical care area admission is required
排除标准
- •Age less than 18 years
- •Patients who have received more than 2000ml of non study fluid prior to study enrolment
- •Serum Na > 155 or <120 mmol/L
- •Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148
- •Patients with hyperosmotic hyperglycaemic non-ketotic syndrome
- •Other clinical conditions that preclude large volumes of fluid resuscitation
- •Previous inclusion in BEST-DKA trial
研究组 & 干预措施
Plasma-Lyte® 148
Plasma-Lyte® 148 fluid 1L given intravenously for fluid replacement
干预措施: Plasma-Lyte 148 (Drug)
0.9% sodium chloride
Normal saline fluid 1L given intravenously for fluid replacement
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Hospital free days (HFD) up to day-28 after study enrolment
时间窗: from time of enrolment to 28 days
Number of hospital free days from time of hospital discharge
次要结局
- Acute kidney injury assessed by comparing serum creatinine using Kidney Disease: Improving Global Outcomes (KDIGO) criteria(28 days after enrolment)
- ICU and hospital readmissions up to 28 days after study enrolment(28 days after enrolment)
- Duration of IV insulin infusion(from time of enrolment to day 28)
- ICU free days up to 28 days after study enrolment(28 days after enrolment)
- Time to resolution of ketosis(from time of enrolment to day 28)
- Cumulative insulin dosage in the first 48 hours(first 48 hours from time of enrolment)
- Cumulative potassium replacement(from time of enrolment to day 28)
- Episodes of post-study enrolment decrease in Glasgow Coma Scale (GCS) by more than 2 in the first 24 hours(first 24 hours from enrolment)