Lactate and Hypoglycemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Institut d'Anesthesiologie des Alpes Maritimes.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes
ClinicalTrials.gov Identifier:
NCT01387477
First received: June 30, 2011
Last updated: July 1, 2011
Last verified: June 2011

June 30, 2011
July 1, 2011
June 2011
June 2012   (final data collection date for primary outcome measure)
Area under the curve of the glycemia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01387477 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lactate and Hypoglycemia
Comparison of Two Strategies of Hypoglycemia Correction in ICU

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypoglycemia
  • Drug: Lactate
    Infusion of 66 mmol of lactate
  • Drug: Glucose
    Infusion of 33 mmol of glucose
  • Experimental: Lactate
    infusion of 66 mmol of lactate
    Intervention: Drug: Lactate
  • Active Comparator: glucose
    infusion of 33 mmol of glucose
    Intervention: Drug: Glucose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • hypoglycemia under 0.6 g/L

Exclusion Criteria:

  • hepatic failure
  • hyperlactatemia above 5 mmol/L
Both
18 Years to 80 Years
No
Contact: Jean-Christophe Orban, MD orban.jc@chu-nice.fr
France
 
NCT01387477
IAAM 2011-01
No
Jean-Christophe Orban, Carole Ichai
Institut d'Anesthesiologie des Alpes Maritimes
Not Provided
Principal Investigator: Jean-Christophe Orban, MD Nice University Hospital
Institut d'Anesthesiologie des Alpes Maritimes
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP