Evaluation of Glycemic Variability (GLAIVE)

University Hospital, Lille172 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

172

Conditions

Critical Illness Anesthesia

Interventions

Edelvaiss Multiline-8DEVICE

Optimised infusion line

Standard infusion lineDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

index GLI (Glycemic Lability Index)

This index is calculated from capillary blood glucose.

Time frame: up to 48 hours

Secondary Outcomes

Number of hypoglycaemic events

Prevalence and incidence of hypoglycemia

Time frame: 48 hours

Number of hyperglycaemic events

Prevalence and incidence of hyperglycemia

Time frame: 48 hours

Sequential Organ Failure Assessment score (SOFA)

for measure morbidity and mortality

Time frame: during the 4 days of hospitalization period

length of stay in Intensive Care Unit (ICU) or in hospital

for measure morbidity and mortality

Time frame: during the 4 days of hospitalization period

Death rate

for measure morbidity and mortality

Time frame: during the 4 days of hospitalization period

Mean Amplitude Glycemic Excusions score (MAGE)

Glycaemic variability

Time frame: every 3 hours during 48 hours

standard deviation of blood glucose

Glycaemic variability

Time frame: every 3 hours during 48 hours

average blood glucose

Glycaemic variability

Data from ClinicalTrials.gov

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