Tight Glycemic Control in Acute Exacerbations of COPD
Primary Purpose
COPD, Hyperglycemia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tight insulin treatment in patients hospitalized with COPD exacerbation
tight glycemic control
Sponsored by
About this trial
This is an interventional diagnostic trial for COPD focused on measuring inpatients with COPD, glucose control
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
mortality
Secondary Outcome Measures
hospialization
Full Information
NCT ID
NCT00452296
First Posted
March 25, 2007
Last Updated
June 25, 2012
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00452296
Brief Title
Tight Glycemic Control in Acute Exacerbations of COPD
Official Title
Tight Glycemic Control in Acute Exacerbations of COPD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Hyperglycemia
Keywords
inpatients with COPD, glucose control
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tight insulin treatment in patients hospitalized with COPD exacerbation
Intervention Description
treatment with basal plus bolus insulin
Intervention Type
Procedure
Intervention Name(s)
tight glycemic control
Intervention Description
treatment with basal and bolus insulin
Primary Outcome Measure Information:
Title
mortality
Time Frame
one year
Secondary Outcome Measure Information:
Title
hospialization
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idit F Liberty
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Tight Glycemic Control in Acute Exacerbations of COPD
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