Evaluation of Glycemic Variability (GLAIVE)

Anesthesia Clinical Trial

— GLAIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812927
• Other study ID #: 2011_17
• Secondary ID: 2012-A00188-35
• Status: Completed
• Phase: N/A
• First received: June 22, 2016
• Last updated: June 27, 2016
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: June 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anesthesia
• Critical Illness

Intervention

Device:
• Edelvaiss Multiline-8
Optimised infusion line
• Standard infusion line

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	index GLI (Glycemic Lability Index)	This index is calculated from capillary blood glucose.	up to 48 hours	No
Secondary	Number of hypoglycaemic events	Prevalence and incidence of hypoglycemia	48 hours	No
Secondary	Number of hyperglycaemic events	Prevalence and incidence of hyperglycemia	48 hours	No
Secondary	Sequential Organ Failure Assessment score (SOFA)	for measure morbidity and mortality	during the 4 days of hospitalization period	No
Secondary	length of stay in Intensive Care Unit (ICU) or in hospital	for measure morbidity and mortality	during the 4 days of hospitalization period	No
Secondary	Death rate	for measure morbidity and mortality	during the 4 days of hospitalization period	No
Secondary	Mean Amplitude Glycemic Excusions score (MAGE)	Glycaemic variability	every 3 hours during 48 hours	No
Secondary	standard deviation of blood glucose	Glycaemic variability	every 3 hours during 48 hours	No
Secondary	average blood glucose	Glycaemic variability	every 3 hours during 48 hours	No