Lactate to Treat Hypoglycemia

Institut d'Anesthesiologie des Alpes Maritimes

Status and phase: Withdrawn; Phase 4

Conditions: Hypoglycemia

Treatments: Drug: Glucose; Drug: Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT01387477

IAAM 2011-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hypoglycemia under 0.6 g/L

Exclusion criteria

• hepatic failure
• hyperlactatemia above 5 mmol/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Lactate

Experimental group

Description:

infusion of 66 mmol of lactate

Treatment:

Drug: Lactate

glucose

Active Comparator group

Description:

infusion of 33 mmol of glucose

Treatment:

Drug: Glucose