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Lactate and Hypoglycemia

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Institut d'Anesthesiologie des Alpes Maritimes

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE July 4, 2011
Last Update Posted Date July 4, 2011
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
Area under the curve of the glycemia [ Time Frame: 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2011)
  • Bispectral index variation [ Time Frame: 60 minutes ]
  • Maximum change in glycemia [ Time Frame: 30 minutes ]
  • Changes in growth hormone and cortisol [ Time Frame: 180 minutes ]
  • Need for glucose infusion for persistent hypoglycemia [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactate and Hypoglycemia
Official Title  ICMJE Comparison of Two Strategies of Hypoglycemia Correction in ICU
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypoglycemia
Intervention  ICMJE
  • Drug: Lactate
    Infusion of 66 mmol of lactate
  • Drug: Glucose
    Infusion of 33 mmol of glucose
Study Arms  ICMJE
  • Experimental: Lactate
    infusion of 66 mmol of lactate
    Intervention: Drug: Lactate
  • Active Comparator: glucose
    infusion of 33 mmol of glucose
    Intervention: Drug: Glucose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • hypoglycemia under 0.6 g/L

Exclusion Criteria:

  • hepatic failure
  • hyperlactatemia above 5 mmol/L
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01387477
Other Study ID Numbers  ICMJE IAAM 2011-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jean-Christophe Orban, Carole Ichai
Study Sponsor  ICMJE Institut d'Anesthesiologie des Alpes Maritimes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Christophe Orban, MD Nice University Hospital
PRS Account Institut d'Anesthesiologie des Alpes Maritimes
Verification Date June 2011

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