A multicentre cluster crossover randomized controlled trial of Normal Saline versus Ringer Lactate as fluid therapy for critically ill children and adults with Diabetic Ketoacidosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 20
- 主要终点
- Hospital-free days
研究概览
简要总结
Diabetic ketoacidosis (DKA), a life-threatening complication of Diabetes, is associated with substantial morbidity and mortality. India has more than 65 million cases of Diabetes and an estimated 500000 cases of DKA annually with the highest prevalence in younger patients.
*Objectives:*In critically ill adult and paediatric patients with DKA, to determine if fluid therapy with RL compared to NS increases the number of “days alive and out of hospitalâ€
Methods: A multicentre randomized cluster cross-over trial
Novelty: This will be the largest trial in India comparing two commonly used IV fluids in patients with DKA.
Expected Outcome: This innovative trial will examine the safety and efficacy of a widely used intervention on a clinically relevant endpoint- “days alive and out of hospital†, and thereby generating new knowledge. Reducing length of stay by one day would also lead to savings of 7000 INR per patient per day to the healthcare system
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All Patients admitted to ED/ICU with a diagnosis of DKA with all of the following criteria: Blood glucose level more than 250 mg/dl pH less than 7.25 serum bicarbonate more than 15 mmol/L Anion gap more than 12 mmol/L Ketonemia/ketonuria.
排除标准
- •Patients with hyperosmotic hyperglycemic non-ketotic syndrome.
结局指标
主要结局
Hospital-free days
时间窗: 28th day
次要结局
- Secondary Outcome(ICU free days up to 28 days after randomisation)
研究者
Dr Jayashree Muralidharan
PGIMER Hospital Chandigarh