Clinical trial NCT02822976: HbA1c and Outcomes in the Critically Ill
Official title: The Association Between Glycosylated Hemoglobin A1c (HbA1c) and Outcomes in the Critically Ill
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newcomers to the the McGill University Health Center adult medical and surgical ICUs.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: ICU mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: One year mortality
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: ICU and Hospital Length of Stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Days on Mechanical Ventilation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Serious infections
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Renal failure requiring dialysis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
measure: Prevalence of pre-diabetes and diabetes in the critically ill
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre: Royal Victoria Hospital and Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Roupen Hatzakorzian, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: