Skip to content

Lactate to Treat Hypoglycemia

Comparison of Two Strategies of Hypoglycemia Correction in ICU

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01387477
Enrollment
0
Registered
2011-07-04
Start date
2011-06-30
Completion date
2012-06-30
Last updated
2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia

Keywords

hypoglycemia, lactate, glucose, ICU

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.

Interventions

DRUGLactate

Infusion of 66 mmol of lactate

DRUGGlucose

Infusion of 33 mmol of glucose

Sponsors

Institut d'Anesthesiologie des Alpes Maritimes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* hypoglycemia under 0.6 g/L

Exclusion criteria

* hepatic failure * hyperlactatemia above 5 mmol/L

Design outcomes

Primary

MeasureTime frame
Area under the curve of the glycemia30 minutes

Secondary

MeasureTime frame
Bispectral index variation60 minutes
Maximum change in glycemia30 minutes
Changes in growth hormone and cortisol180 minutes
Need for glucose infusion for persistent hypoglycemia30 minutes

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026