Anesthesia, Critical Illness
Conditions
Keywords
Glycemic lability index, Continuous glucose monitoring system, intensive care, Insulin
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.
Interventions
DEVICEEdelvaiss Multiline-8
Optimised infusion line
DEVICEStandard infusion line
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| index GLI (Glycemic Lability Index) | up to 48 hours | This index is calculated from capillary blood glucose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of hypoglycaemic events | 48 hours | Prevalence and incidence of hypoglycemia |
| Number of hyperglycaemic events | 48 hours | Prevalence and incidence of hyperglycemia |
| Sequential Organ Failure Assessment score (SOFA) | during the 4 days of hospitalization period | for measure morbidity and mortality |
| length of stay in Intensive Care Unit (ICU) or in hospital | during the 4 days of hospitalization period | for measure morbidity and mortality |
| Death rate | during the 4 days of hospitalization period | for measure morbidity and mortality |
| Mean Amplitude Glycemic Excusions score (MAGE) | every 3 hours during 48 hours | Glycaemic variability |
| standard deviation of blood glucose | every 3 hours during 48 hours | Glycaemic variability |
| average blood glucose | every 3 hours during 48 hours | Glycaemic variability |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGilles Lebuffe, MD, PhD
University Hospital of Lille
Outcome results
None listed