Lactate to Treat Hypoglycemia
Primary Purpose
Hypoglycemia
Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Lactate
Glucose
Sponsored by
About this trial
This is an interventional treatment trial for Hypoglycemia focused on measuring hypoglycemia, lactate, glucose, ICU
Eligibility Criteria
Inclusion Criteria:
- hypoglycemia under 0.6 g/L
Exclusion Criteria:
- hepatic failure
- hyperlactatemia above 5 mmol/L
Sites / Locations
- Réanimation médico-chirurgicale
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lactate
glucose
Arm Description
infusion of 66 mmol of lactate
infusion of 33 mmol of glucose
Outcomes
Primary Outcome Measures
Area under the curve of the glycemia
Secondary Outcome Measures
Bispectral index variation
Maximum change in glycemia
Changes in growth hormone and cortisol
Need for glucose infusion for persistent hypoglycemia
Full Information
NCT ID
NCT01387477
First Posted
June 30, 2011
Last Updated
July 29, 2020
Sponsor
Institut d'Anesthesiologie des Alpes Maritimes
1. Study Identification
Unique Protocol Identification Number
NCT01387477
Brief Title
Lactate to Treat Hypoglycemia
Official Title
Comparison of Two Strategies of Hypoglycemia Correction in ICU
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Study Start Date
June 2011 (Anticipated)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Anesthesiologie des Alpes Maritimes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia
Keywords
hypoglycemia, lactate, glucose, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactate
Arm Type
Experimental
Arm Description
infusion of 66 mmol of lactate
Arm Title
glucose
Arm Type
Active Comparator
Arm Description
infusion of 33 mmol of glucose
Intervention Type
Drug
Intervention Name(s)
Lactate
Intervention Description
Infusion of 66 mmol of lactate
Intervention Type
Drug
Intervention Name(s)
Glucose
Intervention Description
Infusion of 33 mmol of glucose
Primary Outcome Measure Information:
Title
Area under the curve of the glycemia
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Bispectral index variation
Time Frame
60 minutes
Title
Maximum change in glycemia
Time Frame
30 minutes
Title
Changes in growth hormone and cortisol
Time Frame
180 minutes
Title
Need for glucose infusion for persistent hypoglycemia
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hypoglycemia under 0.6 g/L
Exclusion Criteria:
hepatic failure
hyperlactatemia above 5 mmol/L
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Orban, MD
Organizational Affiliation
Nice University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Réanimation médico-chirurgicale
City
Nice
Country
France
12. IPD Sharing Statement
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Lactate to Treat Hypoglycemia
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