the Maintenance of NormoglycemiaNCT00447239
The Effect of Intensive Insulin Therapy
A study of the Maintenance of Normoglycemia and the Incidence of Ventilator Associated Pneumonia (VAP), run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit. Methods. Prospective, randomized, controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Maintenance of Normoglycemia, the Incidence of Ventilator Associated Pneumonia (VAP), Treatment Period in the Intensive Care Unit
- Type of treatment
- Surgery or procedure
- How many people
- 117 participants
- Where
- 1 siteSlovenia
- Study dates
- Sep 2004to Jul 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgical patients
- mechanical ventilated
- both sex
- older than 18
Who cannot join
- non-surgical patients
- non mechanical ventilated
- younger than 18
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients
Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit.
Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and 6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between 7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments were based on measurements of glucose in capillary blood sample.
Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin infusion; hospital stay
Read the detailed description
see brief summary
- Conditions
- the Maintenance of Normoglycemia, the Incidence of Ventilator Associated Pneumonia (VAP), Treatment Period in the Intensive Care Unit
- Being tested
- glucontrol (insulin therapy)
- Keywords
- mechanical ventilated, surgical patients, pneumonia, blood glucose, insulin infusion, hospital stay
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucontrol (insulin therapy)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of glucose in capillary blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startSep 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Maintenance of NormoglycemiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 117 participants
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Investigators
- Adela Stecher, Principal investigator, Clinical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447239
- Sponsor's protocol ID
- gluco study
- Status last verified
- Mar 2007
- First submitted
- 13 Mar 2007
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensive Insulin Therapy on the Incidence of Ventilator-Associated Pneumonia in Surgical Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00447239
- Acronym / sponsor ID
- gluco study
- Conditions
- the Maintenance of Normoglycemia, the Incidence of Ventilator Associated Pneumonia (VAP), Treatment Period in the Intensive Care Unit
- Keywords
- mechanical ventilated, surgical patients, pneumonia, blood glucose, insulin infusion, hospital stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Jul 2006
- First posted
- 14 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.
Aim. To determine whether the maintenance of normoglycemia decreases the incidence of ventilator associated pneumonia (VAP), reduces its treatment period and the length of stay in the intensive care unit.
Methods. Prospective, randomized, controlled trial. We enrolled 117 mechanically ventilated trauma (71) and abdominal (46) surgical patients, older than 18, of both sex. In 57 patients (strict glucose control group) we aimed to maintain the blood glucose level between 4.4 and 6. 1 mmol/L, while in 60 patients (standard glucose control group) it was maintained between 7.8 and 10.0 mmol/L, with the use of continues insulin infusion. Insulin dose adjustments were based on measurements of glucose in capillary blood sample.
Key words: surgical patients; mechanical ventilation; pneumonia; blood glucose; insulin infusion; hospital stay
Detailed description
see brief summary
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- surgical patients
- mechanical ventilated
- both sex
- older than 18
Key exclusion criteria (4 listed)
- non-surgical patients
- non mechanical ventilated
- younger than 18
- pregnant women
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 |
|---|---|---|
| glucontrol (insulin therapy) | Procedure or surgery | – |
Primary outcome
measurements of glucose in capillary blood sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
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.
Adela Stecher principal investigator
Clinical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of the Maintenance of Normoglycemia and the Incidence of Ventilator Associated Pneumonia (VAP), run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 4 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: finished, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
measurements of glucose in capillary blood sample. 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 24 Oct 2008.