Tight Glycemic Control in Acute Exacerbations of COPD

COPD Clinical Trial

Official title:

Tight Glycemic Control in Acute Exacerbations of COPD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00452296
• Other study ID #: sor450807ctil
• Status: Active, not recruiting
• Phase: N/A
• First received: March 25, 2007
• Last updated: June 25, 2012
• Start date: April 2007
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: December 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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 ? 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• COPD
• Hyperglycemia

Intervention

Drug:
• tight insulin treatment in patients hospitalized with COPD exacerbation
treatment with basal plus bolus insulin

Procedure:
• tight glycemic control
treatment with basal and bolus insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		one year	No
Secondary	hospialization		one year	No