Critical Illness Clinical Trial
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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