HbA1c and Outcomes in the Critically Ill

NCT ID: NCT02822976

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically Ill Patient HbA1c<6.5

Patients admitted to an intensive care unit with a HbA1c \<6.5.

No interventions assigned to this group

Critically Ill Patient HbA1c≥6.5

Patients admitted to an intensive care unit with a HbA1c ≥6.5.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roupen Hatzakorzian, MD

OTHER

Sponsor Role: lead

Responsible Party

Roupen Hatzakorzian, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roupen Hatzakorzian, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

McGill University Health Centre: Royal Victoria Hospital and Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

10-276-BMA

Identifier Type: -

Identifier Source: org_study_id