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Lactate and Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387477
Recruitment Status : Unknown
Verified June 2011 by Institut d'Anesthesiologie des Alpes Maritimes.
Recruitment status was:  Recruiting
First Posted : July 4, 2011
Last Update Posted : July 4, 2011
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes

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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Drug: Lactate Drug: Glucose Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two Strategies of Hypoglycemia Correction in ICU
Study Start Date : June 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Area under the curve of the glycemia [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Bispectral index variation [ Time Frame: 60 minutes ]
  2. Maximum change in glycemia [ Time Frame: 30 minutes ]
  3. Changes in growth hormone and cortisol [ Time Frame: 180 minutes ]
  4. Need for glucose infusion for persistent hypoglycemia [ Time Frame: 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hypoglycemia under 0.6 g/L

Exclusion Criteria:

  • hepatic failure
  • hyperlactatemia above 5 mmol/L

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387477

Contact: Jean-Christophe Orban, MD

Réanimation médico-chirurgicale Recruiting
Nice, France
Contact: Jean-Christophe Orban, MD   
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Principal Investigator: Jean-Christophe Orban, MD Nice University Hospital

Responsible Party: Jean-Christophe Orban, Carole Ichai Identifier: NCT01387477     History of Changes
Other Study ID Numbers: IAAM 2011-01
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Institut d'Anesthesiologie des Alpes Maritimes:

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases