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The Effect of Intensive Insulin Therapy

NCT ID: NCT00447239

Last Updated: 2008-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-07-31

Brief Summary

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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

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see brief summary

Conditions

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

Keywords

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mechanical ventilated surgical patients pneumonia blood glucose insulin infusion hospital stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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glucontrol (insulin therapy)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* non-surgical patients
* non mechanical ventilated
* younger than 18
* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Principal Investigators

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Adela Stecher

Role: PRINCIPAL_INVESTIGATOR

Clinical Centre Ljubljana

Locations

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Clinical Centre Ljubljana

Ljubljana, Ljubljana, Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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gluco study

Identifier Type: -

Identifier Source: org_study_id