Critical IllnessPhase 3NCT00096421
Tight Glycemic Control in Critical Care Patients
A Phase 3 study of Critical Illness and Hyperglycemia, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
Trial summary
The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Critical Illness, Hyperglycemia, Insulin Resistance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 504 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2003to Sep 2006
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15 years of age or older,
- Probability of staying in critical care for more than 48 hours,
- Agreement with the informed consent.
Who cannot join
- Pregnancy,
- Participating in other trials,
- Diabetic keto-acidosis or diabetic hyperosmolar state,
- Moribund
- Do-not-resuscitate orders,
- Reentry to the critical care unit of the same patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study
The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.
Read the detailed description
Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.
Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.
- Conditions
- Critical Illness, Hyperglycemia, Insulin Resistance
- Being tested
- Tight control of blood glucose levels, Conventional control of glucose levels
- Keywords
- Critical illness, Critical care, Hyperglycemia, Intensive care, Intensive Care Units, Insulin resistance, Intensive insulin therapy, Conventional insulin therapy
- Medical subject headings
- Critical Illness, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tight control of blood glucose levelsBehavioural
Conventional control of glucose levelsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in the next 28 days
Secondary outcomes (10)
Mortality during intensive care
Mortality overall in-hospital
Mortality among patients who remained in the intensive care unit for more than five days
Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
Length of stay in the unit
Days of ventilatory support
Acute renal failure requiring dialysis or hemofiltration
The median number of red-cell transfusions
SOFA score
Critical-illness polyneuropathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2004 (estimated)
- Study startJul 2003
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants
Sponsor and investigators
- Lead sponsor
- Hospital Pablo Tobón Uribe
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Investigators
- Gisela D De La Rosa, MD, Principal investigator, Hospital Pablo Tobon Uribe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096421
- Sponsor's protocol ID
- 4374-04-13031
- Other IDs
- 094-2003.
- Status last verified
- Oct 2006
- First submitted
- 9 Nov 2004
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study
- ClinicalTrials.gov ID
- NCT00096421
- Acronym / sponsor ID
- 4374-04-13031
- Conditions
- Critical Illness, Hyperglycemia, Insulin Resistance
- Keywords
- Critical illness, Critical care, Hyperglycemia, Intensive care, Intensive Care Units, Insulin resistance, Intensive insulin therapy, Conventional insulin therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants
- Lead sponsor
- Hospital Pablo Tobón UribeUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Jul 2003
- Study completion
- Sep 2006
- First posted
- 10 Nov 2004 (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.
The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.
Detailed description
Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.
Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 15 years of age or older,
- Probability of staying in critical care for more than 48 hours,
- Agreement with the informed consent.
Key exclusion criteria (6 listed)
- Pregnancy,
- Participating in other trials,
- Diabetic keto-acidosis or diabetic hyperosmolar state,
- Moribund
- Do-not-resuscitate orders,
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 control of blood glucose levels | Behavioural | – |
| Conventional control of glucose levels | Behavioural | – |
Primary outcome
Mortality in the next 28 days
10 secondary outcomes
Mortality during intensive care
Mortality overall in-hospital
Mortality among patients who remained in the intensive care unit for more than five days
Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
Length of stay in the unit
Days of ventilatory support
Acute renal failure requiring dialysis or hemofiltration
The median number of red-cell transfusions
SOFA score
Critical-illness polyneuropathy
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 26 Oct 2006.
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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.
Gisela D De La Rosa, MD principal investigator
Hospital Pablo Tobon Uribe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Critical Illness and Hyperglycemia, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
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 3 inclusion and 6 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 26 Oct 2006. 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 Colombia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mortality in the next 28 days. 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 Oct 2006.