Lactate and Hypoglycemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoglycemia |
Drug: Lactate Drug: Glucose |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Comparison of Two Strategies of Hypoglycemia Correction in ICU |
- Area under the curve of the glycemia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- Bispectral index variation [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
- Maximum change in glycemia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- Changes in growth hormone and cortisol [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
- Need for glucose infusion for persistent hypoglycemia [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- hypoglycemia under 0.6 g/L
Exclusion Criteria:
- hepatic failure
- hyperlactatemia above 5 mmol/L
Contacts and Locations| Contact: Jean-Christophe Orban, MD | orban.jc@chu-nice.fr |
| France | |
| Réanimation médico-chirurgicale | Recruiting |
| Nice, France | |
| Contact: Jean-Christophe Orban, MD orban.jc@chu-nice.fr | |
| Principal Investigator: | Jean-Christophe Orban, MD | Nice University Hospital |
More Information
No publications provided
| Responsible Party: | Jean-Christophe Orban, Carole Ichai |
| ClinicalTrials.gov Identifier: | NCT01387477 History of Changes |
| Other Study ID Numbers: | IAAM 2011-01 |
| Study First Received: | June 30, 2011 |
| Last Updated: | July 1, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:
|
hypoglycemia lactate glucose ICU |
Additional relevant MeSH terms:
|
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013