跳至主要内容
临床试验/NCT03974321
NCT03974321已完成不适用

Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
Acute Myocardial Infarction

研究概览

简要总结

Acute myocardial infarction (MI) is a significant complication following non-cardiac surgery. We sought to evaluate incidence of perioperative MI, its preoperative - and intraoperative - risk factors and outcomes after this complication.

详细描述

Background:

In Sweden, over 800 000 patents undergo surgery each year. Worldwide, the number of surgical procedures yearly is over 310 million. Surgical care is en essential part of the advancement in treating disease, associated with increased lift expectancy a d improved quality of life. However as surgical volume continues to grow, the number of patients who suffer postoperative complications will also increase.

Hemodynamic instability in the perioperative period is frequent and there has been a cumulative interest in this area and the relation to organ failure over the recent years. There are several studies showing results of associations between intraoperative hypotensive events and perioperative cardiac, kidney and cerebral injury, as well as increased mortality in high-risk surgical patients.

More specifically the project aims to answer how intraoperative events, with a special focus on hypotension, are related to perioperative myocardial and kidney injury.

We hypothesize that patients, with preoperative risk factors, undergoing major non-cardiac surgery are at increased risk of developing perioperative organ damage in the presence of intraoperative hypotension or other events such as tachycardia, hypoxia and extensive blood loss.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Adults (≥18 years), male and female.
  • Undergoing elective or non-elective in-patients non-cardiac surgery at 3 University Hospitals in Sweden: Karolinska University hospital, Skåne University hospital and Norrland University hospital.
  • Surgeries performed between 2007 and
  • Acute myocardial infarction criteria fulfilled within 30 days after surgery.

排除标准

  • Cardiac surgery
  • Obstetric surgery
  • Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery.

结局指标

主要结局

Acute Myocardial Infarction

时间窗: Within 30 days after the index surgery

Acute MI, detected in the postoperative phase in the electronic medical records or in the Swedeheart Registry

次要结局

  • Mortality(Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.)

研究者

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

Max Bell

MD, PhD, Associate Professor, Senior Lecturer

Karolinska Institutet

研究点 (1)

Loading locations...

相似试验

Intraoperative Hypotension and Perioperative... | 临床试验