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Completed

NCT Number: NCT02822976

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Montreal, Quebec, H3A 1A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Hospital mortality

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

Secondary outcomes

  1. ICU mortality

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

  2. One year mortality

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

  3. ICU and Hospital Length of Stay

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

  4. Days on Mechanical Ventilation

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

  5. Serious infections

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

  6. Renal failure requiring dialysis

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Roupen Hatzakorzian, MD

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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