Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries … (NCT05336864) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery
Switzerland650 participantsStarted 2022-05-20
Plain-language summary
The aim of study is to investigate the clinical relevance of blood pressure (BP) excursions below cerebral autoregulatory boundaries in major noncardiac surgery. The study seeks to establish a precedent for a personalized definition of intraoperative arterial hypotension based on non-invasive tissue oxygenation measurements. The feasibility of NIRS-based autoregulation monitoring in major noncardiac surgery and the prognostic relevance of BP excursions below the NIRS-derived lower limit of autoregulation (LLA) with regard to major cardiovascular, renal and neurological complications will be investigated.
Who can participate
Age range
45 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 (All patients):
* undergoing major noncardiac surgery in general anesthesia will be included. Major noncardiac surgery is defined as:
* vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
* intraperitoneal surgery
* intrathoracic surgery
* major orthopedic surgery
* at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
* preoperative NT-proBNP ≥ 200 ng/l
* history of coronary artery disease
* history of peripheral vascular disease
* history of stroke
* undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies
* fulfillment of any 3 of the 8 following criteria:
* undergoing major surgery (intrathoracic, intraperitoneal or suprainguinal vascular surgery)
* any history of CHF or history of pulmonary edema
* anamnestic transient ischemic attack (TIA)
* diabetes under treatment with either oral antidiabetic agent or insulin
* age \> 70 years
* history of hypertension
* serum creatinine \> 175 mcmol/l or calculated creatinine clearance \< 60 l/min/1.73m2 (Cockroft Gault)
* history of smoking within 2 years of surgery
* intraoperative continuous invasive blood pressure monitoring indicated due to anesthetic or surgical factors
* planned surgical time ≥ 90 minutes
* planned postoperative hospital stay at least 1 night
Additional inclusion crit…
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 looking at blood pressure drops during surgery and whether they cause organ damage afterward — if I'm having major noncardiac surgery, is my blood pressure management plan something we should talk about before I go into the operating room?
2Since this study is actively monitoring patients on postoperative days 1 through 3 for signs of organ injury, does my surgical team already track those kinds of complications as part of routine care, or would participating in this trial add extra monitoring I wouldn't otherwise get?
3The trial is no longer enrolling new patients — does that mean any findings from it might already be influencing how my surgical team manages blood pressure during my operation, or is that kind of research still being analyzed?
4This study focuses on something called cerebral autoregulatory boundaries, which sounds like it involves brain blood flow — should I be asking my anesthesiologist whether they use any special monitoring to track that kind of thing during my surgery?
5Given that this is an observational study about what happens during surgery rather than a treatment trial, would my doctor say the safest approach for me right now is to focus on standard blood pressure management guidelines, or is there a reason to seek out a center that actively researches this area?
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
Perioperative organ injury on postoperative days 1-3, a composite of: