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
  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

Resource links provided by NLM:


Further study details as provided by Institut d'Anesthesiologie des Alpes Maritimes:

Primary Outcome Measures:
  • Area under the curve of the glycemia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • hypoglycemia under 0.6 g/L

Exclusion Criteria:

  • hepatic failure
  • hyperlactatemia above 5 mmol/L
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387477

Contacts
Contact: Jean-Christophe Orban, MD orban.jc@chu-nice.fr

Locations
France
Réanimation médico-chirurgicale Recruiting
Nice, France
Contact: Jean-Christophe Orban, MD       orban.jc@chu-nice.fr   
Sponsors and Collaborators
Institut d'Anesthesiologie des Alpes Maritimes
Investigators
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 July 26, 2014