HyperglycemiaNCT00854347
Hyperglycemia in the Intensive Care Unit, a Prevalence Study
An observational study of Hyperglycemia and Diabetes, run by Université de Montréal.
Trial summary
Hyperglycemia is very common among critically ill patients, even in the absence of diagnosed diabetes or pre-diabetes. We aimed to determine the prevalence of occult glucose metabolism abnormalities in a general intensive care unit (ICU) and hypothesized that hyperglycemia severity, as reflected by insulin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Diabetes
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Feb 2007
- Phase
- Observational
- 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
Study population: All adults patients with an expected stay of 24 hours or more who are admitted to our 28 beds ICU tertiary center Sacré-Coeur Hospital ICU.
Who may be able to join
- All consecutive ICU adult patients with an expected LOS of at least 24 hours.
Who cannot join
- We excluded patients with a previous diagnosis of diabetes or pre-diabetes. Patients admitted for diabetic ketoacidosis or hyperglycemic hyperosmolar states, treated with chronic corticosteroid therapy at supraphysiological doses or enrolled in another exclusive study were also excluded.
About this study
Official title: Hyperglycemia in the Intensive Care Unit Marker of Diabetes or Pre-Diabetes ?
Hyperglycemia is very common among critically ill patients, even in the absence of diagnosed diabetes or pre-diabetes.
We aimed to determine the prevalence of occult glucose metabolism abnormalities in a general intensive care unit (ICU) and hypothesized that hyperglycemia severity, as reflected by insulin requirements for maintenance of normoglycemia, could be used as a tool to identify high risk patients.
Read the detailed description
100 consecutive adults patients with an expected stay of 24 hours or more admitted to the Sacré-Coeur Hospital ICU between November 2005 and March 2006 were eligible for enrollment. Our hospital is a 28 beds ICU tertiary center affiliated with the University of Montreal. We have a mixed medical and surgical ICU units treating patients with a variety of conditions including sepsis, respiratory failure, circulatory insufficiency, trauma, as well as cardiac, thoracic and vascular surgery. We excluded patients with a previous diagnosis of diabetes or pre-diabetes. Patients admitted for diabetic ketoacidosis or hyperglycemic hyperosmolar states, treated with chronic corticosteroid therapy at supraphysiological doses or enrolled in another exclusive study were also excluded.
Data collection
At time of admission, demographic data were collected and classical risk factors for diabetes, including high blood pressure, dyslipidemia, coronary artery disease, vascular disease and family history of type 2 diabetes were assessed. Corticosteroid exposure in the 72 hours preceding admission was noted. Physiology and laboratory data were collected for calculation of the Acute Physiologic and Chronic Health Evaluation (APACHE-II) score of illness severity. For each patient, body mass index (BMI) was calculated and waist circumference was measured according to standard technique .
All patients had strict glycemic control according to local regular insulin protocol. Bedside glucose measurements were made every two to four hours using a calibrated plasma glucometer (EliteTM by Bayer). We calculated the daily and cumulative insulin dose administered during the first 72 hours in the ICU in order to maintain a blood glucose level between 72 and 126 mg per deciliter. Co-treatment with other forms of insulin and oral hypoglycaemic agents was prohibited during the study. The daily caloric intake, including feeding, dextrose solution, medication diluent and propofol, as well as the corticosteroids and vasopressors received during that period of time were also calculated.
Random plasma glucose level and glycated hemoglobin (A1C, Homogenous Immunoturbimetric Assay) were measured at baseline. Three months after ICU admission, a second value of A1C was obtained and a standard 75g Oral Glucose Tolerance Test (OGTT) was performed. Based on the OGTT results, patients were classified as having normal or abnormal glucose metabolism according to the criteria published by the American Diabetes Association.
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- hyperglycemia, diabetes, intensive care, prevalence
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of diabetes and prediabetes.
Measured: 3 months post admission
Secondary outcomes (1)
Evaluate insulin needs capacity to predict subsequent diagnosis of diabetes and prediabetes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startNov 2005
- Primary completionAug 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Investigators
- Martin Albert, MD, Principal investigator, Centre de Recherche Hopital du Sacre-Coeur de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854347
- Sponsor's protocol ID
- 1-Albert
- Status last verified
- Nov 2008
- First submitted
- 2 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycemia in the Intensive Care Unit Marker of Diabetes or Pre-Diabetes ?
- ClinicalTrials.gov ID
- NCT00854347
- Acronym / sponsor ID
- 1-Albert
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- hyperglycemia, diabetes, intensive care, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 3 Mar 2009 (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.
Hyperglycemia is very common among critically ill patients, even in the absence of diagnosed diabetes or pre-diabetes.
We aimed to determine the prevalence of occult glucose metabolism abnormalities in a general intensive care unit (ICU) and hypothesized that hyperglycemia severity, as reflected by insulin requirements for maintenance of normoglycemia, could be used as a tool to identify high risk patients.
Detailed description
100 consecutive adults patients with an expected stay of 24 hours or more admitted to the Sacré-Coeur Hospital ICU between November 2005 and March 2006 were eligible for enrollment. Our hospital is a 28 beds ICU tertiary center affiliated with the University of Montreal. We have a mixed medical and surgical ICU units treating patients with a variety of conditions including sepsis, respiratory failure, circulatory insufficiency, trauma, as well as cardiac, thoracic and vascular surgery. We excluded patients with a previous diagnosis of diabetes or pre-diabetes. Patients admitted for diabetic ketoacidosis or hyperglycemic hyperosmolar states, treated with chronic corticosteroid therapy at supraphysiological doses or enrolled in another exclusive study were also excluded.
Data collection
At time of admission, demographic data were collected and classical risk factors for diabetes, including high blood pressure, dyslipidemia, coronary artery disease, vascular disease and family history of type 2 diabetes were assessed. Corticosteroid exposure in the 72 hours preceding admission was noted. Physiology and laboratory data were collected for calculation of the Acute Physiologic and Chronic Health Evaluation (APACHE-II) score of illness severity. For each patient, body mass index (BMI) was calculated and waist circumference was measured according to standard technique .
All patients had strict glycemic control according to local regular insulin protocol. Bedside glucose measurements were made every two to four hours using a calibrated plasma glucometer (EliteTM by Bayer). We calculated the daily and cumulative insulin dose administered during the first 72 hours in the ICU in order to maintain a blood glucose level between 72 and 126 mg per deciliter. Co-treatment with other forms of insulin and oral hypoglycaemic agents was prohibited during the study. The daily caloric intake, including feeding, dextrose solution, medication diluent and propofol, as well as the corticosteroids and vasopressors received during that period of time were also calculated.
Random plasma glucose level and glycated hemoglobin (A1C, Homogenous Immunoturbimetric Assay) were measured at baseline. Three months after ICU admission, a second value of A1C was obtained and a standard 75g Oral Glucose Tolerance Test (OGTT) was performed. Based on the OGTT results, patients were classified as having normal or abnormal glucose metabolism according to the criteria published by the American Diabetes Association.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults patients with an expected stay of 24 hours or more who are admitted to our 28 beds ICU tertiary center Sacré-Coeur Hospital ICU.
Key inclusion criteria (1 listed)
- All consecutive ICU adult patients with an expected LOS of at least 24 hours.
Key exclusion criteria (1 listed)
- We excluded patients with a previous diagnosis of diabetes or pre-diabetes. Patients admitted for diabetic ketoacidosis or hyperglycemic hyperosmolar states, treated with chronic corticosteroid therapy at supraphysiological doses or enrolled in another exclusive study were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of diabetes and prediabetes.
Time frame: 3 months post admission
1 secondary outcome
Evaluate insulin needs capacity to predict subsequent diagnosis of diabetes and prediabetes
Time frame: 3 months
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 3 Mar 2009.
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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.
Martin Albert, MD principal investigator
Centre de Recherche Hopital du Sacre-Coeur de Montreal
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Diabetes, run by Université de Montréal.
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 1 inclusion and 1 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 3 Mar 2009. 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?
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?
Prevalence of diabetes and prediabetes. (time frame: 3 months post admission). 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 3 Mar 2009.