HbA1c and Outcomes in the Critically Ill

Critical Illness Clinical Trial

Official title:

The Association Between Glycosylated Hemoglobin A1c (HbA1c) and Outcomes in the Critically Ill

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822976
• Other study ID #: 10-276-BMA
• Status: Completed
• Phase: N/A
• First received: June 22, 2015
• Last updated: October 10, 2016
• Start date: September 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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.

Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is associated with poor outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: June 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Canada	McGill University Health Centre: Royal Victoria Hospital and Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Roupen Hatzakorzian, MD

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Hospital mortality		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	ICU mortality		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	One year mortality		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	ICU and Hospital Length of Stay		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Days on Mechanical Ventilation		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Serious infections		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Secondary	Renal failure requiring dialysis		Participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No