Critically Ill PatientsPhase 2NCT00288743
Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study
A Phase 2 study testing to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL. in people with Critically Ill Patients, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
There is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. To target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dL. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2002to Dec 2002
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgical or medical critically ill patients
- An expected ICU-stay of more than 72 hours
- Age > 16 years
- Need for insulin therapy
- Patients must have an arterial line
Who cannot join
- Patients who did not respond to the inclusion criteria
- Patients with diabetic ketoacidosis
- Cardiac surgical patients
- Patients transferred from other hospitals
- Other study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
There is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. To target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dL.
- Conditions
- Critically Ill Patients
- Being tested
- to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL.Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients
Secondary outcomes (1)
To determine potential factors associated with blood glucose control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startSep 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Sandra Oeyen, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288743
- Sponsor's protocol ID
- 2002/087
- Status last verified
- Dec 2007
- First submitted
- 7 Feb 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence, Efficacy and Safety of an Insulin Protocol in the Critically Ill: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT00288743
- Acronym / sponsor ID
- 2002/087
- Conditions
- Critically Ill Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Dec 2002 (actual)
- First posted
- 8 Feb 2006 (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.
There is a growing body of evidence in the literature regarding the adverse effects of hyperglycemia in critically ill patients. To target and maintain better blood glucose regulation we implemented an insulin protocol with target blood glucose levels between 81-110 mg/dL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Surgical or medical critically ill patients
- An expected ICU-stay of more than 72 hours
- Age > 16 years
- Need for insulin therapy
- Patients must have an arterial line
Key exclusion criteria (5 listed)
- Patients who did not respond to the inclusion criteria
- Patients with diabetic ketoacidosis
- Cardiac surgical patients
- Patients transferred from other hospitals
- Other study enrollment
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 |
|---|---|---|
| to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL. | Drug | – |
Primary outcome
To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients
1 secondary outcome
To determine potential factors associated with blood glucose control
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 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Sandra Oeyen, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing to implement an insulin protocol with target blood glucose levels between 81-110 mg/dL. in people with Critically Ill Patients, run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 5 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 28 Dec 2007. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To evaluate compliance, efficacy and safety of an insulin protocol, with target glycemia between 81-110 mg/dL in critically ill patients. 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 28 Dec 2007.