The Effect of Intensive Insulin Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447239
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : October 24, 2008
Information provided by:
University Medical Centre Ljubljana

March 13, 2007
March 14, 2007
October 24, 2008
September 2004
Not Provided
measurements of glucose in capillary blood sample
Same as current
Complete list of historical versions of study NCT00447239 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
The Effect of Intensive Insulin Therapy
The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients

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

see brief summary
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • the Maintenance of Normoglycemia
  • the Incidence of Ventilator Associated Pneumonia (VAP)
  • Treatment Period in the Intensive Care Unit
Procedure: glucontrol (insulin therapy)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2006
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • non-surgical patients
  • non mechanical ventilated
  • younger than 18
  • pregnant women
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
gluco study
Not Provided
Not Provided
Not Provided
University Medical Centre Ljubljana
Not Provided
Principal Investigator: Adela Stecher Clinical Centre Ljubljana
University Medical Centre Ljubljana
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP