COPDNCT00452296
Tight Glycemic Control in Acute Exacerbations of COPD
A study testing tight insulin treatment in patients hospitalized with COPD exacerbation in people with COPD and Hyperglycemia, run by Soroka University Medical Center.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- COPD, Hyperglycemia
- What is being tested?
- tight insulin treatment in patients hospitalized with COPD exacerbation
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- respiratory failure (pH<7.35 ו Pco2>60 )
- pneumonia
- pneumothorax
- bronchiectasis
- lung collapse
- congestive heart failure
Show all 12Show fewer
- lung cancer
- suspected pulmonary emboli
- immune deficiency (acquired 0r congenital)
- cystic fibrosis
- post lung implantation
- asthma/ non smokers
About this study
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.
Read more
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.
- Conditions
- COPD, Hyperglycemia
- Being tested
- tight insulin treatment in patients hospitalized with COPD exacerbation, tight glycemic control
- Keywords
- inpatients with COPD, glucose control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tight insulin treatment in patients hospitalized with COPD exacerbationDrug
treatment with basal plus bolus insulin
tight glycemic controlProcedure or surgery
treatment with basal and bolus insulin
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: one year
Secondary outcomes (1)
hospialization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2010
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idit F Liberty, Soroka University Medical Center
- Investigators
- Idit F Liberty, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452296
- Sponsor's protocol ID
- sor450807ctil
- Status last verified
- Jun 2012
- First submitted
- 25 Mar 2007
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Glycemic Control in Acute Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT00452296
- Acronym / sponsor ID
- sor450807ctil
- Conditions
- COPD, Hyperglycemia
- Keywords
- inpatients with COPD, glucose control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 27 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- respiratory failure (pH<7.35 ו Pco2>60 )
- pneumonia
- pneumothorax
- bronchiectasis
- lung collapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tight insulin treatment in patients hospitalized with COPD exacerbationtreatment with basal plus bolus insulin | Drug | – |
| tight glycemic controltreatment with basal and bolus insulin | Procedure or surgery | – |
Primary outcome
mortality
Time frame: one year
1 secondary outcome
hospialization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit F Liberty principal investigator
Soroka University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing tight insulin treatment in patients hospitalized with COPD exacerbation in people with COPD and Hyperglycemia, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.