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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
History of Changes
  Purpose

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 Intervention
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.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • measurements of glucose in capillary blood sample

Estimated Enrollment: 117
Study Start Date: September 2004
Estimated Study Completion Date: July 2006
Detailed Description:

see brief summary

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00447239     History of Changes
Other Study ID Numbers: gluco study
Study First Received: March 13, 2007
Last Updated: October 23, 2008
Health Authority: Slovenia: Ministry of Health
United States: Food and Drug Administration

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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013