The Effect of Intensive Insulin Therapy - Full Text View

Sponsored by:	University Medical Centre Ljubljana
Information provided by:	University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT00447239

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)

MedlinePlus related topics: Pneumonia

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients

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

Study ID Numbers:	gluco study
Study First Received:	March 13, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00447239
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

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Critical Illness
Lung Diseases

Pneumonia, Ventilator-Associated
Insulin
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009