跳至主要内容
临床试验/NCT02394288
NCT02394288已完成不适用

Perioperative High-sensitivity Cardiac Troponin Levels in Healthy Adults Undergoing Elective Trauma Surgery

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Perioperative change of high-sensitivity cardiac troponin plasma level

研究概览

简要总结

This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-35 years
  • Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder.
  • Planned overnight hospital admission
  • No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1)
  • American Society of Anesthesiologists (ASA) physical status I-II

排除标准

  • Any history or symptoms of cardiac disease
  • Kidney or liver disease
  • Recent or current trauma to the trunk or head
  • Persons with increased vulnerability (e.g. cognitive limitations, prisoners,...)
  • Pregnancy

结局指标

主要结局

Perioperative change of high-sensitivity cardiac troponin plasma level

时间窗: 24 hours preoperatively to postoperative day (POD) 1

3 samples: 1. Preoperative, 2. POD 0, and 3. POD 1

次要结局

  • Incidence rate of high-sensitivity cardiac troponin plasma level elevation(24 hours preoperatively to POD 1)
  • Peak high-sensitivity cardiac troponin plasma level(24 hours preoperatively to POD 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Duma

MD, MSc

Medical University of Vienna

研究点 (1)

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