RecruitingNCT05336864

Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery

Association of Intraoperative Blood Pressure Excursions Below Cerebral Autoregulatory Boundaries With Organ Injury Following Major Noncardiac Surgery (AUTOREGULATE-NONCARDIAC)

Sponsor

University Hospital, Basel, Switzerland

Enrollment

650 participants

Start Date

May 20, 2022

Study Type

OBSERVATIONAL

Conditions

Intraoperative Arterial Hypotension

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.

Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether blood pressure drops below a patient's own safe range during major non-cardiac surgery lead to organ injury (kidney, heart, or brain damage) after the operation. Using a brain-based monitoring technique to define each patient's individualized safe blood pressure range, it aims to improve surgical safety. You may be eligible if: - You are 45 years old or older - You are undergoing major non-cardiac surgery (vascular, abdominal, chest, or major orthopedic) under general anesthesia - You have at least one cardiovascular risk factor - You will have an arterial line for blood pressure monitoring and will stay in the hospital overnight You may NOT be eligible if: - Your surgery is an emergency - You are pregnant - You have severe kidney disease (creatinine clearance below 30 ml/min) or are on dialysis - You are having urological surgery - You are already enrolled in another study with overlapping endpoints Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNon-invasive cerebral oximetry monitoring

Main study (all patients): Continuous bilateral frontal cerebral near-infrared spectroscopy (NIRS) monitoring will be performed in all patients for the duration of general anesthesia. Intraoperative parameters including NIRS and invasive blood pressure will be collected and recorded in real-time using the software ICM+. Postoperative hemodynamics substudy (facultative): Cerebral NIRS monitoring will be continued postoperatively in a subset of patients being admitted to the ICU.

OTHERadditional perioperative blood sampling

Main study (all patients): Creatinine, high-sensitivity troponin (T hs-cTnT), Growth/Differentiation Factor-15 (GDF-15), Hemoglobin Neurological injury substudy (facultative): Neurofilament Light Chain (NFL) and C-reactive protein (CRP)

OTHERclinical & telephone assessments

Main study (all patients): Telephone follow-up (1-year outcomes).

OTHERNon-invasive somatic oximetry monitoring

Tissue perfusion substudy (facultative): Continuous somatic NIRS monitoring of an extremity (i.e. on skin of leg or arm) will be performed intraoperatively and postoperatively in a subset of patients being admitted postoperatively to the ICU.

OTHERProcessed electroencephalogram (pEEG) monitoring

Processed EEG substudy to explore the relationship between processed EEG-derived depth of anesthesia metrics and cerebral autoregulatory function.

Locations(3)

University Hospital Basel, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy

Basel, Switzerland

Inselspital, Bern University Hospital, Department of Anaesthesiology and Pain Medicine

Bern, Switzerland

Cantonal Hospital St. Gallen, Division of Perioperative Intensive Care Medicine

Sankt Gallen, Switzerland

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NCT05336864