Evaluation of Glycemic Variability (GLAIVE)

Not Applicable

Completed

• Conditions: Critical Illness; Anesthesia
• Interventions: Device: Edelvaiss Multiline-8; Device: Standard infusion line

• Registration Number: NCT02812927
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimised infusion line	Edelvaiss Multiline-8	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.
Standard infusion line	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.

Primary Outcome Measures

Name	Time	Method
index GLI (Glycemic Lability Index)	up to 48 hours	This index is calculated from capillary blood glucose.

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment score (SOFA)	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
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
average blood glucose	every 3 hours during 48 hours	Glycaemic variability
Number of hypoglycaemic events	48 hours	Prevalence and incidence of hypoglycemia
Number of hyperglycaemic events	48 hours	Prevalence and incidence of hyperglycemia