Perioperative Personalized Blood Pressure Management in Patients Having Major Surgery: a Bicentric Prospective Randomized Controlled Interventional Pilot Trial (IMPROVE-pilot)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Individualized MAP target value
研究概览
简要总结
The investigators propose a pilot trial to (1) proof the concept that defining the intraoperative mean arterial pressure (MAP) intervention threshold based on the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring) results in clinically relevant (mean nighttime MAP ± 10 mmHg) different target values compared with using an absolute population-derived MAP intervention threshold of 65 mmHg (primary endpoint); (2) investigate if a personalized perioperative blood pressure management is feasibly in multi-center studies, especially if the target values can be sufficiently achieved (secondary endpoint); (3) study the impact of personalized perioperative blood pressure management on the incidence of myocardial injury after non-cardiac surgery (MINS) (exploratory endpoint); (4) study the impact of personalized perioperative blood pressure management on the incidence of acute kidney injury within the first three postoperative days according to the KDIGO (Kidney Disease: Improving Global Outcomes) definition without oliguric criteria (exploratory endpoint).
详细描述
not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In control group patients, the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring. Participants and outcomes assessors are blinded to group allocation.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status class (ASA) II-IV
- •scheduled for elective major surgery under general anesthesia
- •surgery expected to last ≥ 120 minutes
排除标准
- •emergency surgery
- •patients having liver or kidney transplantation
- •laparoscopic surgery
- •pregnancy
- •status of post transplantation of kidney, liver, heart, or lung
- •sepsis (according to current Sepsis-3 definition)
- •impossibility of preoperative automated blood pressure monitoring
- •MAP differences between the right and the left arm of more than 20 mmHg surgery that requires controlled hypotension
研究组 & 干预措施
Personalized management group
Intraoperative MAP will be maintained at least at the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring). If the mean nighttime MAP is below 65 mmHg, intraoperative MAP will be maintained at least at 65 mmHg.
干预措施: Personalized management (Other)
Control group
Routine intraoperative blood pressure management with a lower intervention threshold of 65 mmHg. In contrast to the patients in the personalized management group, the individual mean nighttime MAP assessed using preoperative automated blood pressure monitoring is not taken into account and the treating anesthesiologists are blinded to the data of preoperative automated blood pressure monitoring.
结局指标
主要结局
Individualized MAP target value
时间窗: 1 day before surgery
Difference between intraoperative target MAP (defined as the mean nighttime MAP assessed using preoperative automated blood pressure monitoring) and 65 mmHg; we consider a difference \> ± 10 mmHg as clinically meaningful.
次要结局
- Duration and severity of MAP below MAP target(day of surgery)
- Proportion of patients with calculated MAP target(day of surgery)