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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
Soroka University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD focused on measuring inpatients with COPD, glucose control

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 25, 2007
    Last Updated
    June 25, 2012
    Sponsor
    Soroka University Medical Center
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    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

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