Lactate to Treat Hypoglycemia

Hypoglycemia Clinical Trial

Official title:

Comparison of Two Strategies of Hypoglycemia Correction in ICU

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01387477
• Other study ID #: IAAM 2011-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2020
• Source: Institut d'Anesthesiologie des Alpes Maritimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• hypoglycemia under 0.6 g/L

Exclusion Criteria:

• hepatic failure

• hyperlactatemia above 5 mmol/L

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• Lactate
Infusion of 66 mmol of lactate
• Glucose
Infusion of 33 mmol of glucose

Locations

Country	Name	City	State
France	Réanimation médico-chirurgicale	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Anesthesiologie des Alpes Maritimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of the glycemia		30 minutes
Secondary	Bispectral index variation		60 minutes
Secondary	Maximum change in glycemia		30 minutes
Secondary	Changes in growth hormone and cortisol		180 minutes
Secondary	Need for glucose infusion for persistent hypoglycemia		30 minutes