search
Back to results

Lactate to Treat Hypoglycemia

Primary Purpose

Hypoglycemia

Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Lactate
Glucose
Sponsored by
Institut d'Anesthesiologie des Alpes Maritimes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoglycemia focused on measuring hypoglycemia, lactate, glucose, ICU

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 30, 2011
Last Updated
July 29, 2020
Sponsor
Institut d'Anesthesiologie des Alpes Maritimes
search

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Withdrawn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

Learn more about this trial

Lactate to Treat Hypoglycemia

We'll reach out to this number within 24 hrs