Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative De… (NCT07713121) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery
Germany3,432 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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)
Exclusion Criteria:
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically for older patients with high blood pressure having non-cardiac surgery — does my situation match those criteria closely enough that it's even worth discussing enrollment when recruitment opens?
2The trial is testing whether keeping blood pressure at 85 mmHg or higher during surgery reduces the chances of delirium in the first 3 days after the operation — can you explain how my blood pressure is currently managed during surgery, and whether this approach differs from what you'd normally do for me?
3Since this trial hasn't started recruiting yet, what is the realistic timeline for when I might be able to participate, and would waiting affect my treatment options in the meantime?
4Postoperative delirium seems to be a real risk for older patients having surgery — regardless of this trial, what steps do you already take to reduce that risk, and are there proven standard strategies we should be using for my care?
5Because this is listed as Phase NA, which typically means it's testing a procedure or strategy rather than a drug, what does that mean for what's already known about the safety and potential benefit of maintaining higher blood pressure targets during my surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Delirium within the first 3 postoperative days (binary outcome)