HbA1c and Outcomes in the Critically Ill

NCT02822976 | Completed

• 1 other identifier: 10-276-BMA
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients admitted to an intensive care unit within 48 hours

You may not qualify if:

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

Sponsors & Collaborators

• Roupen Hatzakorzian, MD: lead

Study Sites (1)

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

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roupen Hatzakorzian, MD, MSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 6, 2016
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)