Lactate to Treat Hypoglycemia

Comparison of Two Strategies of Hypoglycemia Correction in ICU

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypoglycemia
• Intervention / Treatment: Drug: Lactate; Drug: Glucose

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Réanimation médico-chirurgicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• hypoglycemia under 0.6 g/L

Exclusion Criteria:

• hepatic failure
• hyperlactatemia above 5 mmol/L

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactate; infusion of 66 mmol of lactate	Drug: Lactate; Infusion of 66 mmol of lactate
Active Comparator: glucose; infusion of 33 mmol of glucose	Drug: Glucose; Infusion of 33 mmol of glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve of the glycemia	30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut d'Anesthesiologie des Alpes Maritimes
• Investigators: Principal Investigator: Jean-Christophe Orban, MD, Nice University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: June 30, 2011
• First Submitted That Met QC Criteria: July 1, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: hypoglycemia; ICU; glucose; lactate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: IAAM 2011-01