Comparison of Two Strategies of Hypoglycemia Correction in ICU
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Area under the curve of the glycemia
研究概览
简要总结
Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hypoglycemia under 0.6 g/L
排除标准
- •hepatic failure
- •hyperlactatemia above 5 mmol/L
研究组 & 干预措施
Lactate
infusion of 66 mmol of lactate
干预措施: Lactate (Drug)
glucose
infusion of 33 mmol of glucose
干预措施: Glucose (Drug)
结局指标
主要结局
Area under the curve of the glycemia
时间窗: 30 minutes
次要结局
- Bispectral index variation(60 minutes)
- Need for glucose infusion for persistent hypoglycemia(30 minutes)
- Maximum change in glycemia(30 minutes)
- Changes in growth hormone and cortisol(180 minutes)
研究者
Professor C ICHAI
Professor Chair of IAAM
Institut d'Anesthesiologie des Alpes Maritimes
