Association of Cardiac and Inflammatory Bio Markers and Morbidity in Emergency High-risk Abdominal Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Severe complication (Clavien Dindo ≥ 3)
研究概览
简要总结
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.
详细描述
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:
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
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Severe complication (Clavien Dindo ≥ 3)
时间窗: 30 days
Death
时间窗: 30 days
次要结局
- Length of hospital stay(30 days)
- Death(90 days)
- Length of ICU stay(30 days)
研究者
Sofia Kärnsund
Principal Investigator
Copenhagen University Hospital, Hvidovre