Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| DRUG | Lactate | Infusion of 66 mmol of lactate |
| DRUG | Glucose | Infusion 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.