Evaluation of Glycemic Variability (GLAIVE)

Study Overview
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Brief Summary
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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.

Official Title
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Study of Glycemic Variability in Post-operative Intensive Care Unit Patients According to Two Insulin Infusion Techniques

Conditions
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Critical Illness, Anesthesia

Intervention / Treatment
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* Device: Edelvaiss Multiline-8
* Device: Standard infusion line


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard infusion line<br>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<br> <br> |
| Experimental: Optimised infusion line<br>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<br>* Optimised infusion line<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| index GLI (Glycemic Lability Index) | This index is calculated from capillary blood glucose. | up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycaemic events | Prevalence and incidence of hypoglycemia | 48 hours | 
| Number of hyperglycaemic events | Prevalence and incidence of hyperglycemia | 48 hours | 
| Sequential Organ Failure Assessment score (SOFA) | for measure morbidity and mortality | during the 4 days of hospitalization period | 
| length of stay in Intensive Care Unit (ICU) or in hospital | for measure morbidity and mortality | during the 4 days of hospitalization period | 
| Death rate | for measure morbidity and mortality | during the 4 days of hospitalization period | 
| Mean Amplitude Glycemic Excusions score (MAGE) | Glycaemic variability | every 3 hours during 48 hours | 
| standard deviation of blood glucose | Glycaemic variability | every 3 hours during 48 hours | 
| average blood glucose | Glycaemic variability | every 3 hours during 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycemic lability index, Continuous glucose monitoring system, intensive care, Insulin