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CompletedNCT00447239Updated Oct 24, 2008

The Effect of Intensive Insulin Therapy

An interventional study of glucontrol (insulin therapy) in the Maintenance of Normoglycemia, the Incidence of Ventilator Associated Pneumonia (VAP) and Treatment Period in the Intensive Care Unit, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-24.

Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit.

Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and 6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between 7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments were based on measurements of glucose in capillary blood sample.

Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin infusion; hospital stay

Read the detailed description

see brief summary

02

Conditions studied

  • the Maintenance of Normoglycemia
  • the Incidence of Ventilator Associated Pneumonia (VAP)
  • Treatment Period in the Intensive Care Unit

Keywords

  • mechanical ventilated
  • surgical patients
  • pneumonia
  • blood glucose
  • insulin infusion
  • hospital stay
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 117 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • surgical patients
  • mechanical ventilated
  • both sex
  • older than 18

Exclusion criteria

Exclusion Criteria:

  • non-surgical patients
  • non mechanical ventilated
  • younger than 18
  • pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
117 participants

Interventions

  • Procedureglucontrol (insulin therapy)
06

What researchers measure

Primary outcomes

  1. measurements of glucose in capillary blood sample

07

Study locations

1 site
  • Clinical Centre Ljubljana
    Ljubljana, 1000, Slovenia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00447239
Lead sponsor
University Medical Centre Ljubljana
First posted
Mar 14, 2007
Start date
Sep 2004
Completion
Jul 2006
Last update
Oct 24, 2008

Study contacts

Adela Stecher
principal investigator · Clinical Centre Ljubljana

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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