Status:
RECRUITING
Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Intraoperative Arterial Hypotension
Eligibility:
All Genders
45+ years
Brief 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 precede...
Detailed Description
Major adverse cardiovascular events (MACE) are leading causes of perioperative morbidity and mortality following major noncardiac surgery. Intraoperative arterial hypotension is strongly associated wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT05336864
Start Date
May 20 2022
End Date
January 1 2027
Last Update
July 17 2025
Active Locations (3)
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1
University Hospital Basel, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy
Basel, Switzerland, 4031
2
Inselspital, Bern University Hospital, Department of Anaesthesiology and Pain Medicine
Bern, Switzerland, 3010
3
Cantonal Hospital St. Gallen, Division of Perioperative Intensive Care Medicine
Sankt Gallen, Switzerland, 9007