Investigating blood pressure changes during major noncardiac surgery
Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery (AUTOREGULATE-NONCARDIAC)
This study looks at how changes in blood pressure during major surgeries not related to the heart can affect the risk of serious complications like heart, kidney, and brain problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 3 sites (Basel and 2 other locations) |
| Trial ID | NCT05336864 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the significance of blood pressure fluctuations that fall below the cerebral autoregulatory limits during major noncardiac surgeries. It will utilize non-invasive tissue oxygenation measurements to define intraoperative arterial hypotension more personally. The study will assess the relationship between these blood pressure excursions and the occurrence of major cardiovascular, renal, and neurological complications. Additionally, it will include substudies focusing on perioperative neurologic injury, tissue perfusion, and processed electroencephalogram monitoring.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing major noncardiac surgeries who are at cardiovascular risk.
Not a fit: Patients not undergoing major noncardiac surgery or those without cardiovascular risk factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of blood pressure during surgery, potentially reducing postoperative complications.
How similar studies have performed: While similar studies have shown the importance of autoregulatory thresholds in other clinical settings, this specific approach in major noncardiac surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 criteria for neurologic injury sub-study:
* Age ≥ 65 years
Exclusion Criteria (All patients):
* pregnancy (anamnestic)
* emergent surgery
* urological surgery
* renal insufficiency with creatinine clearance \< 30 ml/min (Cockroft- Gault equation) or on dialysis
* inclusion in an interventional clinical trial with any common endpoints: acute kidney injury, perioperative myocardial injury, components of the composite major cardiovascular, renal and neurological complications up to 1 year following surgery (ACS, CHF, coronary revascularization, stroke, new CKD or progression of CKD, new need for renal replacement therapy, mortality), neurological injury, delirium, exception: potential inclusion of subset of patients in RCT investigating the perioperative use of colchicine in major noncardiac surgery (COLCAT study).
* previously enrolled in this study
Where this trial is running
Basel and 2 other locations
- University Hospital Basel, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy — Basel, Switzerland (Recruiting)
- Inselspital, Bern University Hospital, Department of Anaesthesiology and Pain Medicine — Bern, Switzerland (Recruiting)
- Cantonal Hospital St. Gallen, Division of Perioperative Intensive Care Medicine — Sankt Gallen, Switzerland (Recruiting)
Study contacts
- Principal investigator: Patrick M Wanner, Dr. med. — Clinic for Anaesthesia, University Hospital Basel
- Study coordinator: Patrick M Wanner, Dr. med.
- Email: patrick.wanner@usb.ch
- Phone: +41 61 328 72 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.