The Effect of Intensive Insulin Therapy

the Incidence of Ventilator Associated Pneumonia (VAP) Clinical Trial

Official title:

The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447239
• Other study ID #: gluco study
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: October 23, 2008
• Start date: September 2004
• Est. completion date: July 2006

Study information

• Verified date: March 2007
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

see brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• surgical patients

• mechanical ventilated

• both sex

• older than 18

Exclusion Criteria:

• non-surgical patients

• non mechanical ventilated

• younger than 18

• pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Procedure:
• glucontrol (insulin therapy)

Locations

Country	Name	City	State
Slovenia	Clinical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurements of glucose in capillary blood sample