NCT02812927

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
Last Updated

April 22, 2026

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

June 22, 2016

Last Update Submit

April 17, 2026

Conditions

Critical IllnessAnesthesia

Keywords

Glycemic lability indexContinuous glucose monitoring systemintensive careInsulin

Outcome Measures

Primary Outcomes (1)

  • index GLI (Glycemic Lability Index)

    This index is calculated from capillary blood glucose.

    up to 48 hours

Secondary Outcomes (8)

  • Number of hypoglycaemic events

    48 hours

  • Number of hyperglycaemic events

    48 hours

  • Sequential Organ Failure Assessment score (SOFA)

    during the 4 days of hospitalization period

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

    during the 4 days of hospitalization period

  • Death rate

    during the 4 days of hospitalization period

  • +3 more secondary outcomes

Study Arms (2)

Standard infusion line

OTHER

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.

Device: Standard infusion line

Optimised infusion line

EXPERIMENTAL

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.

Device: Edelvaiss Multiline-8

Interventions

Edelvaiss Multiline-8DEVICE

Optimised infusion line

Optimised infusion line
Standard infusion lineDEVICE
Standard infusion line

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Genay S, Decaudin B, Ethgen S, Alluin A, Babol E, Labreuche J, Behal H, Vantyghem MC, Odou P, Lebuffe G. Effect of insulin infusion line on glycaemic variability in a perioperative high dependency unit (HDU): a prospective randomised controlled trial. Ann Intensive Care. 2017 Dec;7(1):74. doi: 10.1186/s13613-017-0298-x. Epub 2017 Jul 11.

    PMID: 28699150RESULT

MeSH Terms

Conditions

Critical IllnessInsulin Resistance

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gilles Lebuffe, MD, PhD

    University Hospital of Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

September 1, 2014

Last Updated

April 22, 2026

Record last verified: 2016-06