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

NCT05336864 | Recruiting

• 1 other identifier: 2022-00298; am22Wanner
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Intraoperative Arterial Hypotension

Keywords

cerebral autoregulation; major cardiovascular, renal and neurological complications; hypotension; perioperative myocardial injury; perioperative acute kidney injury; neurological injury; Neurofilament Light Chain (NFL); C-reactive protein (CRP); near-infrared spectroscopy (NIRS)

Outcome Measures

Primary Outcomes (1)

• Perioperative organ injury on postoperative days 1-3, a composite of:

  o perioperative myocardial injury (defined as an absolute perioperative rise in high-sensitivity troponin T \[hsTnT\] of ≥ 14 ng/l above preoperative values or between two postoperative measurements, if preoperative hs-cTnT is missing) and/or o perioperative acute kidney injury (defined as absolute perioperative increase in serum creatinine of \> 26.4 μmol/l or a percentage perioperative increase in serum creatinine of \> 50%)

  postoperative days 1-3

Secondary Outcomes (2)

• Major cardiovascular, renal and neurological complications up to 1 year following surgery, a composite of any of the following:

  up to 1 year following surgery

• Neurological injury (neurological injury sub-study)

  postoperative day 2

Interventions

Non-invasive cerebral oximetry monitoring OTHER

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.

additional perioperative blood sampling OTHER

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)

clinical & telephone assessments OTHER

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

Non-invasive somatic oximetry monitoring OTHER

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.

Processed electroencephalogram (pEEG) monitoring OTHER

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

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be screened for eligibility during the preoperative anesthetic visit based on the inclusion/exclusion criteria and the previous medical history using a standardized checklist, helping to minimize bias.

You may qualify if:

• 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)

You may not qualify if:

• pregnancy (anamnestic)
• emergent surgery
• urological surgery
• renal insufficiency with creatinine clearance \< 30 ml/min (Cockroft- Gault equation) or on dialysis
• previously enrolled in this study

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (3)

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

Basel, 4031, Switzerland

RECRUITING

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

Bern, 3010, Switzerland

RECRUITING

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

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypotension; Trauma, Nervous System; Charcot-Marie-Tooth disease, Type 1F

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Wounds and Injuries

Study Officials

• Patrick M Wanner, Dr. med.

  Clinic for Anaesthesia, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick M Wanner, Dr. med.

CONTACT

+41 61 328 72 54; patrick.wanner@usb.ch

Luzius A Steiner, Prof. Dr. med.

CONTACT

+41 61 328 72 54; luzius.steiner@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: May 20, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CH (3)