NCT03442907已完成不适用
Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 2
- 主要终点
- Composite endpoint: Incidence of POCD or delirium
研究概览
简要总结
The aim of this research project is to find out whether a personalized definition of the lower blood pressure threshold based on the individual blood pressure profile by means of preoperative 24-hour blood pressure measurement can reduce organ damage (brain, kidney, heart) through reduced blood flow during surgery.
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)
入排标准
- 年龄范围
- 50 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnancy
- •Emergency procedures
- •Surgery requiring controlled hypotension (e.g., aneurysm)
- •Cerebrovascular events in the past medical history
- •Patients of cardiac surgery, vascular surgery, neurosurgery, and transplantation surgery
- •Pre-existing dementia (anamnesis)
- •kidney transplant
- •dialysis-dependent renal insufficiency (KDIGO criteria)
- •no patient consent
- •failure to meet the inclusion criteria
- •Impossibility of 24-h blood pressure measurement
结局指标
主要结局
Composite endpoint: Incidence of POCD or delirium
时间窗: 3rd-7th postoperative day
POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test.
次要结局
- Kidney function(24, 48 and 72 hrs after surgery)
- cardiac ischemia(6 hours after surgery)
- length of hospital stay(30 days)
- 30-day morbidity(30 days)
- 30-day mortality(30 days)
研究者
研究点 (2)
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