Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Resolution of diabetic ketoacidosis
研究概览
简要总结
Management of severe diabetic ketoacidosis is based on insulin therapy, correction of metabolic disorders and fluid resuscitation. Current recommendations recommend the first-line use of isotonic saline, whose composition is unbalanced, rich in chloride and sodium compared with plasma. Administration of large volumes of isotonic saline is associated with a risk of hyperchloremic metabolic acidosis and acute renal failure. Balanced solutions (e.g. Ringer Lactate) are solutions with a more balanced electrolyte composition close to that of plasma. They could therefore enable diabetic ketoacidosis to be resolved more quickly than isotonic saline, due to a lower risk of hyperchloremic acidosis. Preliminary data suggest a potential benefit of balanced solutions for fluid resuscitation of patients with severe diabetic ketoacidosis in terms of resolution of diabetic ketoacidosis, but no randomized controlled double-blind study to date has compared balanced solution vs. isotonic saline in this context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Admission to emergency department or direct admission to ICU
- •Diagnosis of severe diabetic ketoacidosis requiring all the following criteria:
- •Blood or capillary glucose > 11 mmol/L
- •Ketonemia or ketonuria > 0
- •Venous or arterial pH < 7.30 or venous or arterial bicarbonate < 15 mmol/L
- •Volume of fluid administered before inclusion <1L
排除标准
- •Patients <18 years
- •Pregnant women
- •Patients under protection
- •Patients with a decision to withdraw life-sustaining therapy
- •Contraindication to isotonic saline or Ringer Lactate
- •Non-affiliation to social security
研究组 & 干预措施
Isotonic saline
干预措施: Fluid resuscitation with isotonic saline only (Drug)
Ringer Lactate
干预措施: Fluid resuscitation with Ringer Lactate (Drug)
结局指标
主要结局
Resolution of diabetic ketoacidosis
时间窗: at 24 hours
Compare fluid resuscitaiton with Ringer Lactate to isotonic saline on the resolution of diabetic ketoacidosis at 24 hours from admission to Intensive Care Unit (ICU) in patients with severe diabetic ketoacidosis. Resolution of ketoacidosis allowing discharge from ICU, defined as the proportion of patients with the following three criteria at 24 hours from ICU admission : 1. capillary or blood glucose \< 11 mmol/L 2. undetectable ketonemia or ketonuria 3. venous or arterial pH \> 7.35 or venous or arterial bicarbonate \> 20 mmol/L
次要结局
- Speed of resolution of metabolic disorders(at 48 hours)
- Time of resolution of metabolic disorders(at 48 hours)
- Assess the metabolic tolerance of Ringer Lactate compared to isotonic saline solution(through the end of study average 24 months)
- Assess the impact of Ringer lactate compared with isotonic saline on renal, neurological and cardiac complications(at 28 days)
- Assess the impact of Ringer lactate compared with isotonic saline on cardiac complications(at 28 days)
- Assess the impact of Ringer lactate compared with isotonic saline on renal complications(at 28 days)
- Assess the impact of Ringer lactate compared with isotonic saline on neurological complications(at 28 days)