Clinical Trial: Lactate and Hypoglycemia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Comparison of Two Strategies of Hypoglycemia Correction in ICU

Brief Summary: 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.

Detailed Summary:
Sponsor: Institut d'Anesthesiologie des Alpes Maritimes

Current Primary Outcome: Area under the curve of the glycemia [ Time Frame: 30 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bispectral index variation [ Time Frame: 60 minutes ]
  • Maximum change in glycemia [ Time Frame: 30 minutes ]
  • Changes in growth hormone and cortisol [ Time Frame: 180 minutes ]
  • Need for glucose infusion for persistent hypoglycemia [ Time Frame: 30 minutes ]


Original Secondary Outcome: Same as current

Information By: Institut d'Anesthesiologie des Alpes Maritimes

Dates:
Date Received: June 30, 2011
Date Started: June 2011
Date Completion: June 2012
Last Updated: July 1, 2011
Last Verified: June 2011