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临床试验/NCT02822976
NCT02822976已完成不适用

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

Roupen Hatzakorzian, MD1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,500
试验地点
1
主要终点
Hospital mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to an intensive care unit within 48 hours

排除标准

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

结局指标

主要结局

Hospital mortality

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

次要结局

  • 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)
  • Serious infections(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)
  • Renal failure requiring dialysis(Participants will be followed for the duration of hospital stay, an expected average of 4 weeks)

研究者

发起方
Roupen Hatzakorzian, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Roupen Hatzakorzian, MD

Assistant Professor

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

研究点 (1)

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