Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery

Официальное название

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

Обзор

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.

Вмешательства

• Другое MAP at 85 mmHg or higher (intervention group)
  In patients assigned to the intervention group, clinicians will be instructed to maintain MAP at 85 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.
• Другое MAP at 65 mmHg or higher (control group)
  In patients assigned to the control group, clinicians will be instructed to maintain MAP at 65 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.

Первичные конечные точки

• Delirium within the first 3 postoperative days (binary outcome) [Срок оценки: within the first 3 postoperative days]

Вторичные конечные точки (12)

• Days patients have delirium within the first 3 postoperative days (count outcome) [Срок оценки: within the first 3 postoperative days]
• Delirium within the first 7 postoperative days (binary outcome) [Срок оценки: within the first 7 postoperative days]
• Acute kidney injury within the first 7 postoperative days (binary outcome) [Срок оценки: within the first 7 postoperative days]
• Acute myocardial injury within the first 7 postoperative days (Fourth Universal Definition 2018; binary outcome) [Срок оценки: within the first 7 postoperative days]
• Acute myocardial injury within the first 7 postoperative days (latest definition at time of analysis; binary outcome) [Срок оценки: within the first 7 postoperative days]
• Stroke within the first 7 postoperative days (binary outcome) [Срок оценки: within the first 7 postoperative]
• Days alive and out of hospital within the first 90 postoperative days (count outcome) [Срок оценки: within the first 90 postoperative days]
• Time until all-cause death within the first 90 postoperative days (time-to-event outcome) [Срок оценки: within the first 90 postoperative days]
• Time until discharge from hospital within the first 90 postoperative days (time-to-event outcome) [Срок оценки: within the first 90 postoperative days]
• Long-term cognitive function at postoperative day 180 (continuous outcome) [Срок оценки: postoperative day 180]
• Quality of recovery at postoperative day 2 (continuous outcome) [Срок оценки: postoperative day 2]
• Quality of life at postoperative day 180 (visual analog scale; continuous outcome) [Срок оценки: postoperative day 180]

Критерии участия

Критерии включения

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)

Критерии исключения

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
• sepsis
• surgery in the previous 30 days
• previous participation in ASPIRE-85

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Германия · 1 центр

• • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, Univ — Hamburg

Идентификаторы

NCT: NCT07713121 · 2026-101764-BO-ff

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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