INTRAOPERATIVE HEMODYNAMIC MANAGEMENT in ABDOMINAL AORTIC SURGERY GUIDED by HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Global time spent in hypotension <10%
研究概览
简要总结
This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence
详细描述
The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from.
The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management.
Primary endpoint: Global time spent in hypotension <10%.
Secondary Endpoints:
- Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg
- Incidence of hypotensive events/patient < 8 (including the expected hypotensive events due to the aortic clamping and unclamping)
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients undergoing abdominal aorta open surgical repair
排除标准
- •Emergent/urgent operation
- •Age <18 years
- •Pregnancy
- •Intra-operative blood loss > or = 3000ml
结局指标
主要结局
Global time spent in hypotension <10%
时间窗: Intraoperative period
Hypotension=mean arterial pressure \<65 mmHg for at least 1 minute
次要结局
- Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg(Intraoperative period)
- Incidence of hypotensive events/patient < 8(Intraoperative period)
研究者
Enrico Giustiniano
Dr
Humanitas Clinical and Research Center