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The Prevalence of Hyperglycemia in Surgical Patients With Pre-diabetes

2026年6月17日 更新者:Shannon Ruzycki、University of Calgary

The goal of this study is to measure the prevalence and risks of hyperglycemia in surgical patients with prediabetes. The main questions it aims to answer are:

  • What is the prevalence of hyperglycemia in surgical patients with prediabetes?
  • What is the relative risk of postoperative complications associated with hyperglycemia?

To answer these questions, surgical patients with prediabetes will undergo universal glucose measurement in the perioperative period. Glucose data will be analyzed in conjunction with electronic health record (EHR) data describing patient outcomes.

研究概览

详细说明

Background

Day-of-surgery and postoperative ('perioperative') hyperglycemia are modifiable risk factors for complications after non-cardiac surgery, including surgical site infections, 30-day readmissions, and mortality. Data from Alberta suggests perioperative hyperglycemia is common among people without diabetes, affecting about 13% of people with prediabetes on the day-of-surgery and 18% of people without diabetes after surgery. Paradoxically, the risks of perioperative hyperglycemia appear to be two-times greater for people with prediabetes than for people with diabetes and the reasons for this are unknown. Current estimates of the prevalence of perioperative for people with prediabetes are limited. Understanding the true prevalence would inform individual decision-making around surgery, the need for further research about the true association of hyperglycemia and adverse outcomes, and clinical decisions about the utility of measuring glucose for all people with prediabetes around the time of surgery.

Objectives

This prospective cohort study will establish the prevalence of perioperativehyperglycemia in people with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries. This information will inform:

  1. Patients, to better understand their individual risks of elective surgery.
  2. Clinicians, on the need for perioperative glucose measurement for patients with prediabetes.
  3. Researchers, on the need for and design of further studies.

Methods Overview

We will measure glucose in all adult patients with prediabetes undergoing scheduled (elective and urgent) non-cardiac surgeries throughout the perioperative period (referring to the day of surgery and up to the first 3 postoperative days or discharge, whichever comes first) to determine the prevalence of perioperative dysglycemia in people with prediabetes.

This project will leverage established data sources and linkages to address secondary and exploratory objectives: (1) Use in-hospital insulin prescribing data to describe current practices for treatment of perioperative hyperglycemia in people with prediabetes; (2) Explore the association between clinical outcomes like infections and length of stay with perioperative hyperglycemia in people with prediabetes; and (3) Compare the prevalence of perioperative hyperglycemia and the association of hyperglycemia with clinical outcomes between the intervention period and a historical control period (pre-intervention at the same hospital) and a contemporaneous, non-intervention site (UAH, Edmonton) to examine whether the 'prediabetes paradox' is a result of confounding by indication or another cause.

Outcomes

If the prevalence of perioperative hyperglycemia in people with prediabetes is sufficiently high, clinical guidelines should recommend perioperative glycemic monitoring for patients with prediabetes. Further, if there is an association between hyperglycemia and adverse outcomes, intervention-based studies are needed to determine whether this risk is modifiable with hyperglycemia treatment.

Team

The NPI and co-investigators have led a 5-year implementation science and quality improvement study to improve perioperative glycemic management for people with diabetes in Alberta. This interdisciplinary group of patients, nurses, endocrinologists, surgeons, anesthesiologists, internists, and implementation scientists will leverage their existing data access, professional networks, and content expertise to conduct this study.

研究类型

观察性的

注册 (估计的)

750

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Alberta
      • Calgary、Alberta、加拿大
        • Foothills Medical Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

取样方法

非概率样本

研究人群

Surgical in-patients at the Foothills Medical Centre.

描述

Inclusion Criteria:

  • Hemoglobin A1c measurement between 6 and 6.4%
  • Scheduled for non-cardiac surgery

Exclusion Criteria:

  • Age>18
  • Pregnancy
  • Any formal diabetes diagnosis
  • Current use of medications that influence blood glucose regardless of the indication
  • Undergoing cardiac, intracranial neurosurgery, bariatric, or pancreatic surgeries

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Surgical Patients with Prediabetes
Adult patients undergoing non-cardiac surgeries who have pre-diabetes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of perioperative hyperglycemia
大体时间:Up to the first 3 postoperative days or discharge, whichever comes first.
Prediabetes will be defined as described in Section 4.2 using Diabetes Canada definitions. The perioperative period will include the day of surgery and the early postoperative period. The day of surgery includes surgical admitting, intraoperative, and recovery room on postoperative day (POD) 0, which is the day that surgery was completed until 23:59. The early postoperative period will be defined as the first 3 full postoperative days, in keeping with studies that have demonstrated that hyperglycemia is most common in the first 72 hours after surgery and that early hyperglycemia is associated with greater 30-day postoperative mortality. Hyperglycemia will be defined using Diabetes Canada reference ranges as any glucose value >10.0 mmol/L by any form of glucose measurement.
Up to the first 3 postoperative days or discharge, whichever comes first.

次要结果测量

结果测量
措施说明
大体时间
Post-operative complications
大体时间:Within 30 days of surgery.
Postoperative complications are defined in accordance with the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), a standardized list of preventable complications developed by surgeons and used internationally to describe hospital-level quality of surgical care. These include the following adverse events within 30 days of surgery: SSIs (superficial, deep incisional, organ/space, using the Centres for Disease Control definitions), wound dehiscence, pneumonia, unplanned intubation, pulmonary embolism, ventilator use >48 hours, acute renal failure, urinary tract infection, stroke, cardiac arrest, myocardial infarction, transfusion complications, deep vein thrombosis, sepsis, septic shock, Clostridium difficile infection, death, readmissions, and unplanned reoperations.
Within 30 days of surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Shannon Ruzycki, MD、University of Calgary

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年5月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年2月23日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月23日

研究记录更新

最后更新发布 (实际的)

2026年6月23日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

IPD, specifically deidentified patient data will be shared upon reasonable request by fellow research teams.

IPD 共享时间框架

Data will be available after analyses have completed, approximately in the month of March, 2028. Data will be retained in accordance with the University of Calgary's Master Records Retention Schedule(MaRRS). During this time period, data will be available upon reasonable request.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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