HbA1c and Outcomes in the Critically Ill

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness

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 Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • McGill University Health Centre: Royal Victoria Hospital and Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All newcomers to the the McGill University Health Center adult medical and surgical ICUs.

Description

Inclusion Criteria:

• Patients admitted to an intensive care unit within 48 hours

Exclusion Criteria:

• Patients with known hemoglobinopathy(ies)
• Patients that have received ≥2 units of packed red blood cells 48 hours prior to HbA1c sampling

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospital mortality	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU mortality	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
One year mortality	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
ICU and Hospital Length of Stay	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Days on Mechanical Ventilation	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Serious infections	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Renal failure requiring dialysis	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Prevalence of pre-diabetes and diabetes in the critically ill	Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Roupen Hatzakorzian, MD
• Investigators: Principal Investigator: Roupen Hatzakorzian, MD, MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 30, 2016
• First Posted (Estimate): July 6, 2016

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 10, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 10-276-BMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES