Lactate to Treat Hypoglycemia

Phase 4

Withdrawn

• Conditions: Hypoglycemia
• Interventions: Drug: Lactate; Drug: Glucose

• Registration Number: NCT01387477
• Lead Sponsor: Institut d'Anesthesiologie des Alpes Maritimes

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 Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• hypoglycemia under 0.6 g/L

Exclusion Criteria

• hepatic failure
• hyperlactatemia above 5 mmol/L

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactate	Lactate	infusion of 66 mmol of lactate
glucose	Glucose	infusion of 33 mmol of glucose

Primary Outcome Measures

Name	Time	Method
Area under the curve of the glycemia	30 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Réanimation médico-chirurgicale; 🇫🇷 Nice, France