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The Effect of Intensive Insulin Therapy

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Slovenia

Study Type

Interventional

Intervention

glucontrol (insulin therapy)

About this trial

This is an interventional prevention trial for the Maintenance of Normoglycemia focused on measuring mechanical ventilated, surgical patients, pneumonia, blood glucose, insulin infusion, hospital stay

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

surgical patients
mechanical ventilated
both sex
older than 18

Exclusion Criteria:

non-surgical patients
non mechanical ventilated
younger than 18
pregnant women

Sites / Locations

Clinical Centre Ljubljana

Outcomes

Primary Outcome Measures

measurements of glucose in capillary blood sample

Secondary Outcome Measures

Full Information

NCT ID

NCT00447239

First Posted

March 13, 2007

Last Updated

October 23, 2008

Sponsor

University Medical Centre Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT00447239

Brief Title

The Effect of Intensive Insulin Therapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee

Yes

5. 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

Detailed Description

see brief summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

mechanical ventilated, surgical patients, pneumonia, blood glucose, insulin infusion, hospital stay

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

117 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

glucontrol (insulin therapy)

Primary Outcome Measure Information:

Title

measurements of glucose in capillary blood sample

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adela Stecher

Organizational Affiliation

Clinical Centre Ljubljana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Centre Ljubljana

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

12. IPD Sharing Statement

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The Effect of Intensive Insulin Therapy

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