Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 368
- 试验地点
- 1
- 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
- •age ≥ 50 years
- •ASA II-IV (Classification of the American Society of Anesthesiologists for the assessment of the perioperative risk depending on the underlying diseases)
- •duration of intervention in general anesthesia at least 90 minutes
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
研究组 & 干预措施
Study group
The intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement.
To achieve the blood pressure target, fluid or vasoactive substances will be used.
干预措施: 24 hour blood pressure measurement, fluids, vasopressors (Procedure)
Control group
Study patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf.
干预措施: Standard of Care (Procedure)
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)