Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery: the Multicenter Randomized ASPIRE-85 Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,432
- 试验地点
- 2
- 主要终点
- Delirium within the first 3 postoperative days (binary outcome)
研究概览
简要总结
In older patients having surgery, postoperative delirium (an acute disturbance in awareness, attention, or cognition) is common and associated with short-term and long-term morbidity and mortality. The pathophysiology of postoperative delirium is multifactorial - but presumably includes inadequate brain perfusion during surgery caused by low intraoperative blood pressure. Therefore, the investigators aim to determine in a multicenter randomized-controlled trial if targeted intraoperative blood pressure management reduces postoperative delirium. The investigators will test the primary hypothesis that maintaining intraoperative mean arterial pressure at 85 mmHg or higher - compared to at 65 mmHg or higher (routine care) - reduces the incidence of postoperative delirium within the first 3 postoperative days in older patients with arterial hypertension having non-cardiac surgery. The investigators will also assess the duration of postoperative delirium, postoperative complications, and the patients' quality of life. The results of this trial will have a direct impact on guidelines and will help improve medical care for patients and the patients' health. Effective strategies to prevent postoperative delirium are missing. The hypothesis that targeted intraoperative blood pressure management can help reduce postoperative delirium is supported by previous observational studies and interventional trials. This trial is supposed to confirm the causal relationship between intraoperative blood pressure and postoperative delirium and to demonstrate the effectiveness of the therapeutic approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients, outcome assessors, outcome adjudicators, and data analysts will be blinded to treatment allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for trial inclusion, patients must:
- •1) be able to provide informed consent, AND
- •2) be ≥65 years old, AND
- •3) be scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥120 minutes, AND
- •4) have chronic arterial hypertension requiring antihypertensive medication OR have a systolic arterial pressure ≥140 mmHg or diastolic arterial pressure ≥90 mmHg on a measurement performed within the previous year, AND
- •5) be at high risk for postoperative delirium because: American Society of Anesthesiologists physical status class III or IV OR Charlson Comorbidity Index ≥3 points (please see Appendix 1) OR frailty (documented in medical records or clinical diagnosis)
排除标准
- •Patients that meet one or more of the following exclusion criteria cannot participate in the trial:
- •solid organ transplant surgery
- •intracranial surgery
- •surgery in sitting position
- •surgery in the previous 30 days
- •previous participation in ASPIRE-85
结局指标
主要结局
Delirium within the first 3 postoperative days (binary outcome)
时间窗: within the first 3 postoperative days
Delirium will be assessed on the day of surgery after transfer from the post-anesthesia care unit to the general ward or intensive care unit and twice daily on postoperative days 1, 2, and 3. The 3-Minute Diagnostic Confusion Assessment Method will be used for patients on general wards and the Confusion Assessment Method for the Intensive Care Unit for patients in intensive care units.
次要结局
- Days patients have delirium within the first 3 postoperative days (count outcome)(within the first 3 postoperative days)
- Delirium within the first 7 postoperative days (binary outcome)(within the first 7 postoperative days)
- Acute kidney injury within the first 7 postoperative days (binary outcome)(within the first 7 postoperative days)
- Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome)(within the first 7 postoperative days)
- Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome)(within the first 7 postoperative days)
- Stroke within the first 7 postoperative days (binary outcome)(within the first 7 postoperative)
- Days alive and out of hospital within the first 90 postoperative days (count outcome)(within the first 90 postoperative days)
- Time until all-cause death within the first 90 postoperative days (time-to-event outcome)(within the first 90 postoperative days)
- Time until discharge from hospital within the first 90 postoperative days (time-to-event outcome)(within the first 90 postoperative days)
- Long-term cognitive function at postoperative day 180 (continuous outcome)(postoperative day 180)
- Quality of recovery at postoperative day 2 (continuous outcome)(postoperative day 2)
- Quality of life at postoperative day 180 (visual analog scale; continuous outcome)(postoperative day 180)
- Quality of life at postoperative day 180 (index value; continuous outcome)(postoperative day 180)