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Troponin T and Emergency High-risk Abdominal Surgery

2021年5月7日 更新者:Sofia Kärnsund、Copenhagen University Hospital, Hvidovre

Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery

To assess whether perioperatively elevated TnT levels, using high sensitivity troponin T (hsTnT) measurements, are associated with an increased risk of postoperative mortality as well as severe postoperative complications.

研究概览

地位

招聘中

详细说明

Cardiac Troponin T (TnT) is a cardiac-specific molecule, released into the systemic circulation following myocardial cell injury. The release of cardiac Troponins is common during critical illness and is associated with increased morbidity and mortality. The mechanisms by which TnT is released in the blood during critical illness are not fully understood, but sepsis and inflammation are primary non-cardiac conditions during which elevated TnT levels are commonly seen. Previous research has shown that 84 percent of patients admitted to ICU had at least one elevated TnT measurement perioperatively. Patients undergoing high-risk abdominal surgery, defined as immediate emergency laparoscopy or laparotomy, are critically ill, often septic and with an acute inflammatory response and potential multiple organ system dysfunctions both prior but largely after surgery.

The hypothesis is that there is an association between elevated perioperative levels of cardiac Troponin T and mortality in patients undergoing emergency high-risk abdominal surgery.

The primary objective is to assess whether perioperatively elevated TnT levels, using high sensitivity troponin T (hsTnT) measurements, are associated with an increased risk of postoperative mortality as well as severe postoperative complications.

Patients requiring immediate emergency laparotomy or laparoscopy, including reoperations after elective gastrointestinal surgery and reoperations after previous non emergency high-risk abdominal surgery surgery, will be included in the study.

Two primary exposure measures will be investigated:

  1. Peak Troponin T values ≥14 vs. Troponin T values <14. Patients with at least one measured Troponin T value ≥14 postoperatively will be allocated to the "elevated hsTnT" group
  2. Postoperative hsTnT concentration ≥14 as well as a >50% relative increase from preoperative hsTnT concentration. Patients with hsTnT levels meeting these conditions will be allocated to the "elevated hsTnT" group hsTnT will be taken by blood samples preoperatively as well as on postoperative day 1, 2 and 3.

Primary analyses investigating the association between hsTnT and 30-day mortality (yes/no) and severe complications (yes/no) will be done using logistic regression models.

研究类型

观察性的

注册 (预期的)

300

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

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

18年 及以上 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

All patients undergoing emergency high-risk abdominal surgery at Hvidovre Hospital, Denmark, that meet the criteria for inclusion. Hvidovre hospital serves as the primary emergency hospital for more than 500 000 inhabitants.

描述

Inclusion Criteria:

Adults (18 years or over) undergoing emergency laparotomy or laparoscopy for following abdominal pathology:

  • Intestinal obstruction
  • Perforated viscus
  • Intestinal ischemia
  • Intraabdominal bleeding

The above conditions include both primary surgery and re-operation after elective surgery.

Exclusion Criteria:

Patients undergoing

  • Appendicectomies
  • Negative laparoscopies/laparotomies
  • Cholecystectomies
  • Simple herniotomies following incarceration without bowel resection
  • Reoperation due to fascial separation with no other abdominal pathology identified
  • Internal hernia after Roux-en-Y gastric bypass surgery
  • Subacute surgery (surgery planned within 48 h) for inflammatory bowel diseases
  • Subacute colorectal cancer surgery
  • Patients with missing hsTnT values on both postoperative day 1 and 2

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
Emergency high-risk abdominal surgery
Patients undergoing emergency high-risk abdominal surgery, defined as immediate emergency laparoscopy or laparotomy, including intestinal obstruction, perforated viscus, intestinal ischemia and intraabdominal bleeding. Includes both primary surgery and re-operation after elective surgery.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
死亡
大体时间:30天
30天
Severe complication (Clavien Dindo ≥ 3)
大体时间:30 days
30 days

次要结果测量

结果测量
大体时间
住院时间
大体时间:30天
30天
死亡
大体时间:90天
90天
ICU住院时间
大体时间:30天
30天

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。

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 (实际的)

2021年3月1日

初级完成 (预期的)

2022年3月31日

研究完成 (预期的)

2022年7月31日

研究注册日期

首次提交

2021年5月4日

首先提交符合 QC 标准的

2021年5月4日

首次发布 (实际的)

2021年5月7日

研究记录更新

最后更新发布 (实际的)

2021年5月11日

上次提交的符合 QC 标准的更新

2021年5月7日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • H-21012302

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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