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Evaluation of Glycemic Variability (GLAIVE) (GLAIVE)

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ClinicalTrials.gov Identifier: NCT02812927
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:
This study compared two methods of insulin infusion by syringe pumps to assess the impact of medical devices on the glycaemic variability in patients under IIT in ICU. The main objective of the study was to show the superiority of the infusion system which permitted to dedicate a line for the insulin administration on the "standard" installation in terms of control of glycaemic variability.

Condition or disease Intervention/treatment Phase
Critical Illness Anesthesia Device: Edelvaiss Multiline-8 Device: Standard infusion line Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study of Glycemic Variability in Post-operative Intensive Care Unit Patients According to Two Insulin Infusion Techniques
Study Start Date : September 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Standard infusion line
The standard insulin infusion system consisted in regular human insulin administration through a six-stopcock manifold connected to the distal line of a multilumen central venous catheter by 150 cm tubing. Insulin was systematically infused by syringe pump on the patient proximal port of the manifold. Carrier was infused via pump through the manifold. All others medicines were infused through the other five stopcocks.
Device: Standard infusion line
Experimental: Optimised infusion line
The optimised insulin infusion system consisted in regular human insulin administration through a multilumen device (Edelvaiss Multiline-8, Doran International, Toussieu, France). This device had ports for eight infusions which run through separate channels within a 150 cm flexible plastic tube. Since fluids from the individual channels do not meet until they exit the distal tip. Carrier was infused through the high flow (HF) line and insulin was infused by syringe pump systematically next to the HF line port. All others medicines were administered via adjacent ports on the Multiline-8.
Device: Edelvaiss Multiline-8
Optimised infusion line




Primary Outcome Measures :
  1. index GLI (Glycemic Lability Index) [ Time Frame: up to 48 hours ]
    This index is calculated from capillary blood glucose.


Secondary Outcome Measures :
  1. Number of hypoglycaemic events [ Time Frame: 48 hours ]
    Prevalence and incidence of hypoglycemia

  2. Number of hyperglycaemic events [ Time Frame: 48 hours ]
    Prevalence and incidence of hyperglycemia

  3. Sequential Organ Failure Assessment score (SOFA) [ Time Frame: during the 4 days of hospitalization period ]
    for measure morbidity and mortality

  4. length of stay in Intensive Care Unit (ICU) or in hospital [ Time Frame: during the 4 days of hospitalization period ]
    for measure morbidity and mortality

  5. Death rate [ Time Frame: during the 4 days of hospitalization period ]
    for measure morbidity and mortality

  6. Mean Amplitude Glycemic Excusions score (MAGE) [ Time Frame: every 3 hours during 48 hours ]
    Glycaemic variability

  7. standard deviation of blood glucose [ Time Frame: every 3 hours during 48 hours ]
    Glycaemic variability

  8. average blood glucose [ Time Frame: every 3 hours during 48 hours ]
    Glycaemic variability



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

Inclusion Criteria:

  • Patients under postoperative intensive care
  • Treatment with insulin on bi-lumen central venous catheter over than 48 hours
  • Eligibility for interstitial glucose monitoring
  • Blood glucose control every 3 hours

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patient unwilling to participate in the study
  • Patients participating in another study biomedical over the same period
  • Patient can not understand the study and its objectives
  • Patient under guardianship, curatorship
  • Patient malnourished (BMI <18 kg / m²)
  • Patient with morbid obesity (BMI> 40 kg / m²)
  • Patient in shock (septic or hemodynamic)
  • Patients refusing to sign the Medtronic consent on the storage of personal data

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 ClinicalTrials.gov identifier (NCT number): NCT02812927


Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Gilles Lebuffe, MD, PhD University Hospital of Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02812927    
Other Study ID Numbers: 2011_17
2012-A00188-35 ( Other Identifier: ID-RCB number, ANSM )
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University Hospital, Lille:
Glycemic lability index
Continuous glucose monitoring system
intensive care
Insulin
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes