Critical IllnessNCT02822976
HbA1c and Outcomes in the Critically Ill
An observational study of Critical Illness, run by Roupen Hatzakorzian, MD at 1 site in Canada.
Trial summary
Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac surgery, septic and critically ill patient population. It is a promising test to understand the complex relationship between glycemia, diabetes and outcomes in patients admitted to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 2,500 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Jun 2016
- 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 newcomers to the the McGill University Health Center adult medical and surgical ICUs.
Who may be able to join
- Patients admitted to an intensive care unit within 48 hours
Who cannot join
- Patients with known hemoglobinopathy(ies)
- Patients that have received ≥2 units of packed red blood cells 48 hours prior to HbA1c sampling
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre: Royal Victoria Hospital and Montreal General Hospital
Montreal, Quebec, H3A 1A1
About this study
Official title: The Association Between Glycosylated Hemoglobin A1c (HbA1c) and Outcomes in the Critically Ill
Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac surgery, septic and critically ill patient population. It is a promising test to understand the complex relationship between glycemia, diabetes and outcomes in patients admitted to the intensive care unit.
Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is associated with poor outcomes.
Read the detailed description
Objectives: The primary objective of this study is to determine hospital mortality of all newcomers admitted to the ICU, and to compare it between patients with HbA1c <6.5% and ≥6.5%. Other outcomes that will be measured include ICU and one year mortality, ICU and hospital length of stay (LOS), days on mechanical ventilation, serious infection during hospitalization and renal failure requiring dialysis during hospitalization and at 6 months. The investigators will also determine the prevalence of pre-diabetes (HbA1c 6.0-6.4%) and diabetes (≥6.5%) in the critically ill population based on HbA1c levels and monitor glucose control and insulin requirements during the first three days of ICU admission.
Methods: This project is a prospective observational study at the McGill University Health Center adult medical and surgical ICUs. HbA1c is measured at the admission to the ICU. The data are being collected prospectively using Microsoft access data entry. The following parameters will be recorded on admission: admitting diagnosis, sex, age, height, weight, body mass index (BMI), Acute Physiology and Chronic Health Evaluation (APACHE) II score, previous diagnosis of DM, whole blood HbA1c level, blood and plasma glucose levels. With power 80%, type I error 5% and with an expected 25% mortality difference between patients with HbA1c≥6.5 and <6.5, the required sample size is 1800 patients. The data will be presented as mean ± SD unless otherwise specified and statistical significance will be set as P < 0.05. All p-values presented will be 2-tailed.
Significance: The investigators want to demonstrate that HbA1c ≥6.5 on admission to an intensive care unit is associated with increased 6 month mortality and worse outcomes. The investigators will also determine the prevalence of pre-diabetes and diabetes in the critically ill based on HbA1c.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill Patient HbA1c<6.5 | Patients admitted to an intensive care unit with a HbA1c <6.5. | |
| Critically Ill Patient HbA1c≥6.5 | Patients admitted to an intensive care unit with a HbA1c ≥6.5. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes (6)
ICU mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
One year mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
ICU and Hospital Length of Stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Days on Mechanical Ventilation
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Serious infections
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Renal failure requiring dialysis
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2011
- Primary completionJul 2015
- Study completionJun 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roupen Hatzakorzian, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roupen Hatzakorzian, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Roupen Hatzakorzian, MD, MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822976
- Sponsor's protocol ID
- 10-276-BMA
- Status last verified
- Oct 2016
- First submitted
- 22 Jun 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Glycosylated Hemoglobin A1c (HbA1c) and Outcomes in the Critically Ill
- ClinicalTrials.gov ID
- NCT02822976
- Acronym / sponsor ID
- 10-276-BMA
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Roupen Hatzakorzian, MDUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jul 2016 (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.
Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac surgery, septic and critically ill patient population. It is a promising test to understand the complex relationship between glycemia, diabetes and outcomes in patients admitted to the intensive care unit.
Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is associated with poor outcomes.
Detailed description
Objectives: The primary objective of this study is to determine hospital mortality of all newcomers admitted to the ICU, and to compare it between patients with HbA1c <6.5% and ≥6.5%. Other outcomes that will be measured include ICU and one year mortality, ICU and hospital length of stay (LOS), days on mechanical ventilation, serious infection during hospitalization and renal failure requiring dialysis during hospitalization and at 6 months. The investigators will also determine the prevalence of pre-diabetes (HbA1c 6.0-6.4%) and diabetes (≥6.5%) in the critically ill population based on HbA1c levels and monitor glucose control and insulin requirements during the first three days of ICU admission.
Methods: This project is a prospective observational study at the McGill University Health Center adult medical and surgical ICUs. HbA1c is measured at the admission to the ICU. The data are being collected prospectively using Microsoft access data entry. The following parameters will be recorded on admission: admitting diagnosis, sex, age, height, weight, body mass index (BMI), Acute Physiology and Chronic Health Evaluation (APACHE) II score, previous diagnosis of DM, whole blood HbA1c level, blood and plasma glucose levels. With power 80%, type I error 5% and with an expected 25% mortality difference between patients with HbA1c≥6.5 and <6.5, the required sample size is 1800 patients. The data will be presented as mean ± SD unless otherwise specified and statistical significance will be set as P < 0.05. All p-values presented will be 2-tailed.
Significance: The investigators want to demonstrate that HbA1c ≥6.5 on admission to an intensive care unit is associated with increased 6 month mortality and worse outcomes. The investigators will also determine the prevalence of pre-diabetes and diabetes in the critically ill based on HbA1c.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically Ill Patient HbA1c<6.5 | – | –Patients admitted to an intensive care unit with a HbA1c <6.5. |
| Critically Ill Patient HbA1c≥6.5 | – | –Patients admitted to an intensive care unit with a HbA1c ≥6.5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All newcomers to the the McGill University Health Center adult medical and surgical ICUs.
Key inclusion criteria (1 listed)
- Patients admitted to an intensive care unit within 48 hours
Key exclusion criteria (2 listed)
- Patients with known hemoglobinopathy(ies)
- Patients that have received ≥2 units of packed red blood cells 48 hours prior to HbA1c sampling
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
Hospital mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
6 secondary outcomes
ICU mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
One year mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
ICU and Hospital Length of Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Days on Mechanical Ventilation
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Serious infections
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Renal failure requiring dialysis
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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 12 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Roupen Hatzakorzian, MD, MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Roupen Hatzakorzian, MD at 1 site in Canada.
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 2 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 12 Oct 2016. 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 Canada. 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?
Hospital mortality (time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks). 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 12 Oct 2016.