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HyperglycemiaNCT00854347

Hyperglycemia in the Intensive Care Unit, a Prevalence Study

An observational study of Hyperglycemia and Diabetes, run by Université de Montréal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. Prevalence of diabetes and prediabetes.

    Measured: 3 months post admission

Secondary outcomes (1)
  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.

  1. First posted3 Mar 2009 (estimated)
  2. Study startNov 2005
  3. Primary completionAug 2006
  4. Study completionFeb 2007

Resources

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)
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

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.

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