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临床试验/NCT05933837
NCT05933837已完成不适用

Association Between Troponin I Levels and Mortality Among Patients Undergoing Acute High-risk Abdominal Surgery - a Cohort Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 341 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
341
试验地点
1
主要终点
The incidence of MINS within the first four postoperative days

研究概览

简要总结

The goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (MINS) in patients undergoing acute high-risk abdominal surgery.

MINS is defined as at least one increased single measurement of plasma troponin I (TnI). TnI-dynamic is defined as either two succeeding measurements of TnI > 59 ng/l with an increase/fall of more than 20%, or by one measurements of TnI > 59 ng/l with a succeeding measurement of TnI < 59 ng/l and a decrease of more than 50%.

Participants will have plasma TnI measured 6-12 hours postoperatively and on each of the following four postoperative days. Follow-up will be minimum one year after surgery.

The aim of the study is to determine:

  • The incidence of MINS within the first four postoperative days
  • The incidence of dynamic TnI changes
  • The association between MINS and dynamic TnI changes respectively and all-course short-term mortality

详细描述

Gastrointestinal tract perforation, bowel ischemia and bowel obstruction are considered acute high-risk abdominal disorders, often requiring emergency surgery. Myocardial injury after non-cardiac surgery (MINS) is a frequent but often unrecognized postoperative complication. MINS is associated with an increased risk of other cardiac complications and 30-day mortality. However, the literature on MINS is mainly regarding patients undergoing a wide range of elective or acute surgical procedures, and we do not know if the dynamic TnI-criteria used for acute myocardial injury has any association with mortality in patients with MINS.

This study aims to estimate the incidence of MINS in patients undergoing AHA surgery, and the association between the short-term mortality and MINS defined as a single increased measurement of TnI and as TnI dynamics respectively.

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

  • 18 years or older
  • Patients undergoing acute high-risk abdominal surgery

排除标准

  • Patients with microscopic perforations in colonic diverticulitis managed with laparoscopic lavage or drainage
  • If further treatment postoperatively was assessed as futile and terminated immediately after surgery

结局指标

主要结局

The incidence of MINS within the first four postoperative days

时间窗: The first four postoperative days

Postoperative troponin I level equal to or above 59 ng/L

次要结局

  • The incidence of dynamic plasma Troponin I changes(The first four postoperative days)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Tiffanie Bendtz Kanstrup

PhD, MD

Nordsjaellands Hospital

研究点 (1)

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