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临床试验/NCT01387477
NCT01387477撤回4 期

Comparison of Two Strategies of Hypoglycemia Correction in ICU

Institut d'Anesthesiologie des Alpes Maritimes1 个研究点 分布在 1 个国家开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

infusion of 66 mmol of lactate

干预措施: Lactate (Drug)

glucose

Active Comparator

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

发起方
Institut d'Anesthesiologie des Alpes Maritimes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor C ICHAI

Professor Chair of IAAM

Institut d'Anesthesiologie des Alpes Maritimes

研究点 (1)

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