Lactate to Treat Hypoglycemia

NCT ID: NCT01387477

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

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.

Conditions

Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lactate

infusion of 66 mmol of lactate

Group Type: EXPERIMENTAL

Lactate

Intervention Type: DRUG

Infusion of 66 mmol of lactate

glucose

infusion of 33 mmol of glucose

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DRUG

Infusion of 33 mmol of glucose

Interventions

Lactate

Infusion of 66 mmol of lactate

Intervention Type: DRUG

Glucose

Infusion of 33 mmol of glucose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• hypoglycemia under 0.6 g/L

Exclusion Criteria

• hepatic failure
• hyperlactatemia above 5 mmol/L

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut d'Anesthesiologie des Alpes Maritimes

OTHER

Sponsor Role: lead

Responsible Party

Professor C ICHAI

Professor Chair of IAAM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Christophe Orban, MD

Role: PRINCIPAL_INVESTIGATOR

Nice University Hospital

Locations

Réanimation médico-chirurgicale

Nice, , France

Countries

France

Other Identifiers

IAAM 2011-01

Identifier Type: -

Identifier Source: org_study_id