Troponin T and Emergency High-risk Abdominal Surgery
Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
研究概览
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:
- 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
- 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
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Sofia Kärnsund
- 电话号码:+4528261925
- 邮箱:sofia.paulina.kaernsund@regionh.dk
学习地点
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Hvidovre、丹麦
- 招聘中
- Copenhagen University Hospital Hvidovre
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接触:
- Sofia Kärnsund, Medical Student
- 电话号码:+4528261925
- 邮箱:sofia.paulina.kaernsund@regionh.dk
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接触:
- Mirjana Cihoric, MD
- 邮箱:mirjana.cihoric.03@regionh.dk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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死亡
大体时间:30天
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30天
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Severe complication (Clavien Dindo ≥ 3)
大体时间:30 days
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30 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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住院时间
大体时间:30天
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30天
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死亡
大体时间:90天
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90天
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ICU住院时间
大体时间:30天
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30天
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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