Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of Intensive Insulin Therapy

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00447239
First received: March 13, 2007
Last updated: October 23, 2008
Last verified: March 2007

March 13, 2007
October 23, 2008
September 2004
Not Provided
measurements of glucose in capillary blood sample
Same as current
Complete list of historical versions of study NCT00447239 on ClinicalTrials.gov 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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
NCT00447239
gluco study
Yes
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