NCT04681508进行中（未招募）不适用
Myocardial Injury After Non-cardiac Surgery (MINS), Acute Kidney Injury (AKI) and Pulmonary Pathology in Patients Undergoing Acute Abdominal Surgery
Nordsjaellands Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Acute kidney Injury
研究概览
简要总结
Explorative study to investigate potential predictors of myocardial injury, acute kidney injury and pulmonary disorder after acute high-risk abdominal surgery.
详细描述
The main issues are:
- To investigate if coronary calcification predisposes the development of myocardial injury and causes an increased mortality rate.
- To evaluate the predictive value of NT-pro-BNP in relation to the development of MINS and the mortality rate.
- To evaluate the predictive value of different biomarkers of AKI in relation to which patients develop AKI.
- To examine the proteins, exosomes and single cell RNA during acute kidney injury in order to describe the molecular processes in the kidney during AKI.
- To examine whether a chest CT scan without contrast enhancement will change treatment decisions in the acute gastrointestinal patient compared with a chest x-ray.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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).
- •Patients included in the AHA regimen undergoing CT on suspicion acute high-risk abdominal disorder e.g.g bowel obstruction GI perforation or ischemia, and need of emergency abdominal surgery, either laparoscopic surgery or laparotomy.
- •Able to speak Danish. In case Danish was not spoken an interpreter was used to obtain the informed consent.
- •Able to give informed consent.
排除标准
- •Patients who cannot give informed consent to participate in the study 15 minutes after receiving verbal information regarding the study.
- •Known chronic kidney disease requiring dialysis at the time of admission (only exclusion criteria for the part of the study relating to AKI).
- •Patients included in the AHA regimen, but conservative treatment is chosen (only exclusion criteria for the part of the study relating to MINS and AKI).
- •Patients not resident in Denmark.
- •Patients not able to give informed consent.
- •Patient not able to speak Danish and not enough time to obtain an interpreter.
结局指标
主要结局
Acute kidney Injury
时间窗: 30 days
According to KIDGO criteria
Proportion of patients with myocardial injury af non-cardiac surgery
时间窗: 30 days
Troponin-I above specified level and dynamic changes
Mortality rate
时间窗: 1 year
Postoperative mortality
Proportion of patients with pulmonary pathology
时间窗: 1 day
Findings (including incidental) on a chest x-ray and chest CT scan without contrast enhancement
Proportion of patients with pulmonary complications
时间窗: 30 days
Postoperative complications
次要结局
未报告次要终点
研究者
研究点 (2)
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