POLECAT: Perioperative Delta Renin Concentration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 405
- 主要终点
- • The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.
研究概览
简要总结
We want to measure the amount of a hormone called renin in people's bodies before and after they have major abdominal surgery. We want to see if changes in renin levels are connected to problems with blood flow, unstable blood pressure, and kidney damage after surgery.
详细描述
The renin-angiotensin system (RAS) plays a key role in haemodynamic stability, vascular tone and electrolyte homeostasis. It is recognised that this system is dysfunctional during critical illness. It remains unknown as to whether significant dysfunction of RAS is found in patients who have undergone major abdominal surgery - however over 50% of these patients often require blood pressure support post-operatively, with nearly half of these patients having unexplained drops in blood pressure.
Renin represents an attractive biomarker that could be implicated in post operative vasoplegia and post operative AKI and as such elevated renin concentrations could be used to identify high-risk patients for cardiovascular instability and AKI who would benefit from timely intervention that could improve their outcomes, this would include the use of selective vasopressor agents such as angiotensin II which has been shown to confer a benefit in patients with underlying dysregulation of the RAS.
If we show that higher differences in renin concentrations are associated with a greater incidence of vasoplegia then we can design a subsequent clinical trial with a different treatment in those who have a higher change in renin. Such a trial is currently recruiting in Germany for patients with higher changes in renin due to cardiac surgery.
The primary aim is to assess whether there is an association between higher differences in renin concentrations (a protein that can be measured in your blood) and haemodynamic instability manifest as vasoplegia (patients exhibiting low blood pressure) in patients undergoing major abdominal surgery requiring post-operative admission to ICU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Age ≥18 years
- •All patients having abdominopelvic surgery (planned or unplanned) needing ICU admission where arterial line or central line will been placed
- •Able to provide consent, or personal/professional agreement
排除标准
- •Patient < 18 years old at time of screening
- •Patients already receiving vasopressor support pre-operatively
- •Receiving palliative care at the time of recruitment or expected to die within next 24 hours
- •Those on kidney replacement therapy (KRT) or end stage kidney disease (ESKD)
- •Patient or consultee unable to communicate in verbal and written English
- •Patients held in an institution by legal or official order
- •Patients with severe mental health disorders that might impair their capacity
结局指标
主要结局
• The difference between pre and post-operative levels of circulating renin, and association with vasoplegia.
时间窗: 2 years
次要结局
- • Association between regular medications that alter the RAS-axis and changes in renin(2 years)
- • Incidence of post-operative AKI in this cohort of patients(2 years)
- • Trends of renin post-operatively following major abdominal surgery.(2 years)
- • Determine overall burden of vasopressor use post operatively.(2 years)
- • Associations between type of surgery and incidence of post operative instability and renin measurements, with specific emphasis on patients with emergency surgery with peritonitis.(2 years)
- • Associations between changes in renin and AKI.(2 years)