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Hypoglycemia | Lactate and Hypoglycemia

Hypoglycemia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - hypoglycemia under 0.6 g/L Exclusion Criteria: - hepatic failure - hyperlactatemia above 5 mmol/L

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypoglycemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:LactateInfusion of 66 mmol of lactate

Drug:GlucoseInfusion of 33 mmol of glucose

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Lactateinfusion of 66 mmol of lactate

glucoseinfusion of 33 mmol of glucose

Study Status

Unknown status

Start Date: June 2011

Completed Date: June 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Area under the curve of the glycemia

Secondary Outcome: Bispectral index variation

Study sponsors, principal investigator, and references

Principal Investigator: Jean-Christophe Orban, MD

Lead Sponsor: Institut d'Anesthesiologie des Alpes Maritimes

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01387477

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