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The Effect of Intensive Insulin Therapy

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ClinicalTrials.gov Identifier: NCT00447239
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:

Study Description
Brief 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


Condition or disease Intervention/treatment
the Maintenance of Normoglycemia the Incidence of Ventilator Associated Pneumonia (VAP) Treatment Period in the Intensive Care Unit Procedure: glucontrol (insulin therapy)

University Medical Centre Ljubljana has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Detailed Description:
see brief summary

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients
Study Start Date : September 2004
Estimated Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. measurements of glucose in capillary blood sample

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • non-surgical patients
  • non mechanical ventilated
  • younger than 18
  • pregnant women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447239


Locations
Slovenia
Clinical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Principal Investigator: Adela Stecher Clinical Centre Ljubljana
More Information

ClinicalTrials.gov Identifier: NCT00447239     History of Changes
Other Study ID Numbers: gluco study
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: March 2007

Keywords provided by University Medical Centre Ljubljana:
mechanical ventilated
surgical patients
pneumonia
blood glucose
insulin infusion
hospital stay

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs