Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01387477

Lactate to Treat Hypoglycemia

Comparison of Two Strategies of Hypoglycemia Correction in ICU

Status
Withdrawn
Phase
Phase 4
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Institut d'Anesthesiologie des Alpes Maritimes · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGLactateInfusion of 66 mmol of lactate
DRUGGlucoseInfusion of 33 mmol of glucose

Timeline

Start date
2011-06-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2011-07-04
Last updated
2020-07-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01387477. Inclusion in this directory is not an endorsement.