Lactate to Treat Hypoglycemia

NCT01387477 | Withdrawn Phase 4

• 1 other identifier: IAAM 2011-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

hypoglycemia; lactate; glucose; ICU

Outcome Measures

Primary Outcomes (1)

• Area under the curve of the glycemia

  30 minutes

Secondary Outcomes (4)

• Bispectral index variation

  60 minutes

• Maximum change in glycemia

  30 minutes

• Changes in growth hormone and cortisol

  180 minutes

• Need for glucose infusion for persistent hypoglycemia

  30 minutes

Study Arms (2)

Lactate

EXPERIMENTAL

infusion of 66 mmol of lactate

Drug: Lactate

glucose

ACTIVE COMPARATOR

infusion of 33 mmol of glucose

Drug: Glucose

Interventions

Lactate DRUG

Infusion of 66 mmol of lactate

Lactate

Glucose DRUG

Infusion of 33 mmol of glucose

glucose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hypoglycemia under 0.6 g/L

You may not qualify if:

• hepatic failure
• hyperlactatemia above 5 mmol/L

Sponsors & Collaborators

• Institut d'Anesthesiologie des Alpes Maritimes: lead

Study Sites (1)

Réanimation médico-chirurgicale

Nice, France

Location

MeSH Terms

Conditions

Hypoglycemia

Interventions

Lactic Acid; Glucose

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Jean-Christophe Orban, MD

  Nice University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Chair of IAAM

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 4, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

FR (1)