Evaluation of Glycemic Variability (GLAIVE)

University Hospital, Lille

Status: Completed

Conditions: Critical Illness; Anesthesia

Treatments: Device: Standard infusion line; Device: Edelvaiss Multiline-8

Study type: Interventional

Funder types: Other

Identifiers

NCT02812927

2011_17

2012-A00188-35 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

172 participants in 2 patient groups

Standard infusion line

Other group

Description:

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.

Treatment:

Device: Standard infusion line

Optimised infusion line

Experimental group

Description:

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.

Treatment:

Device: Edelvaiss Multiline-8