Investigating the Effect of Hypotension Prediction Index Guidance on Intraoperative Hypotension and the Relationships Between the Metabolomic Profile and Postoperative Ileus in Patients Undergoing Major Upper Abdominal Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- time weighted average mean arterial pressure less than 65 mmHg
研究概览
简要总结
We will investigate the effect of hypotension prediction index guidance on intraoperative hypotension and metabolomics in patients undergoing major upper gastrointestinal surgery
详细描述
Intraoperative hypotension (IOH) has been shown to increase the risk of postoperative morbidity and mortality. The Hypotension prediction index (HPI) guidance is an algorithm that can predict impending hypotension, defined as mean arterial pressure below 65mmHg. Patients undergoing major upper abdominal surgery are at high risk of IOH occurrence, because the surgical procedures involve organ removal like intestinal resection and vessel or organ anastomoses or reconstruction, often associated with high blood loss. However, the effectivity of applying HPI for reducing the duration and severity of IOH and postoperative morbidity and mortality in short term within 30 days after surgery and long term within 1 year remains inconclusive.
Postoperative ileus (POI) generally defines absence of flatus within 72 hours after surgery. POI is known as the most important factor to slow patient recovery, increase postoperative morbidity and prolong the hospital stay following major upper abdominal surgery. Metabolomics can investigate the small molecule changes in response to certain stimulus, such as different environments. Metabolomics involves the comprehensive analysis of metabolites. In recent years, metabolomics has several applications in the early diagnosis and prevention of health and disease. However, the association between the POI occurrence and the metabolites in the presence and absence HPI guidance have not yet been investigated.
The proposed strategy and specific objectives of this 2 years project using a randomized controlled trial are as the follows:
- To clarify the relationship of POI occurrence to presence and absence of HPI guidance
- To Explore differences in metabolites in presence or absence of HPI guidance.
- Explore the potential metabolites associated with POI in different intraoperative environment in using HPI and no HPI guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective upper gastrointestinal surgery
排除标准
- •no laparoscopic surgery
研究组 & 干预措施
hypotension prediction index guided
patients with hypotension prediction index guidance
干预措施: hypotension prediction index guidance (Procedure)
结局指标
主要结局
time weighted average mean arterial pressure less than 65 mmHg
时间窗: surgery
the severity and duration of hypotension during surgery
次要结局
未报告次要终点
