Tight Glycemic Control in Acute Exacerbations of COPD

This study is not yet open for participant recruitment.

Verified by Soroka University Medical Center, March 2007

First Received: March 25, 2007 Last Updated: March 26, 2007 History of Changes

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00452296

Purpose

Glucose control has been shown as an important and independent prognostic factor in several acute conditions in hospitalized patients, including Acute MI, stroke, cardiac surgery and in critical care units.

Patients with acute exacerbation of COPD (AECOPD)and diabetes treated with insulin had a longer in-patient stay and more frequent isolation of Gram negative bacteria from sputum than those without diabetes.Hyperglycemia (>11 mmol/l) on admission predicted failure of non-invasive ventilation and infectious pulmonary complications in patients admitted to the ICU with acute respiratory failure caused by severe AECOPD.

The primary goal of this study is to test the hypothesis that in AECOPD, tight glycemic control during hospital stay will improve outcome of hospitalization. The secondary goal of this study is to test new ways in controlling patients in the internal medicine ward.

Condition	Intervention
COPD Hyperglycemia	Drug: tight insulin treatment in patients hospitalized with COPD exacerbation

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Tight Glycemic Control in Acute Exacerbations of COPD

Resource links provided by NLM:

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Estimated Enrollment:	60
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	45 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

current or past smokers (at least 20 py)
patient with COPD be ATS criteria
hospitalized with acute exacerbation, 2/3 criteria:1- worsening of SOB 2-change in sputum volume 3- change in sputum color
signed informed concent

Exclusion Criteria:

respiratory failure (pH<7.35 ו Pco2>60 )
pneumonia
pneumothorax
bronchiectasis
lung collapse
congestive heart failure
lung cancer
suspected pulmonary emboli
immune deficiency (acquired 0r congenital)
cystic fibrosis
post lung implantation
asthma/ non smokers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452296

Contacts

Contact: Idit F Liberty, MD

972-8-6400663

iliberty@bgu.ac.il

Sponsors and Collaborators

Soroka University Medical Center

Investigators

Principal Investigator:

Idit F Liberty

Soroka University Medical Center

More Information

No publications provided

Study ID Numbers:	sor450807ctil
Study First Received:	March 25, 2007
Last Updated:	March 26, 2007
ClinicalTrials.gov Identifier:	NCT00452296 History of Changes
Health Authority:	Israel: Clalit Health Services

Keywords provided by Soroka University Medical Center:

inpatients with COPD
glucose control

Study placed in the following topic categories:

Lung Diseases, Obstructive
Metabolic Diseases
Hyperglycemia
Respiratory Tract Diseases
Lung Diseases

Glucose Metabolism Disorders
Metabolic Disorder
Insulin
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Lung Diseases, Obstructive
Metabolic Diseases
Hyperglycemia
Respiratory Tract Diseases

Lung Diseases
Glucose Metabolism Disorders
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 10, 2009