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

Recruiting

• Conditions: Intraoperative Arterial Hypotension

• Registration Number: NCT05336864
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 with postoperative morbidity and mortality. However, interventional trials have been unable to demonstrate clinically relevant reductions in the incidence of postoperative MACE, which can potentially be explained by the hitherto lacking consideration of patient-specific autoregulatory boundaries. This is especially problematic considering that the presumed mechanism of hypotension-induced organ injury is hypoperfusion due to transgression of the lower limit of blood flow autoregulation. In other clinical settings, excursions below the autoregulatory threshold have been shown to be superior predictors of adverse events than excursions below absolute blood pressure (BP) thresholds, however, there is a paucity of data in major noncardiac surgery.

This prospective, multicenter cohort observation study aims to investigate the clinical relevance of blood pressure excursions below autoregulatory boundaries and to determine the association of other measures of disturbed intraoperative cerebral autoregulatory function in major noncardiac surgery.

This project will consist of a Main study in which all patients will be enrolled and of substudies on perioperative neurologic injury, tissue perfusion, postoperative hemodynamics, and processed electroencephalogram (EEG), in which selected patients will be enrolled.

Study Timeline

• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-20
• Study Start: 2022-05-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative organ injury on postoperative days 1-3, a composite of:	postoperative days 1-3	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%)

Secondary Outcome Measures

Name	Time	Method
Neurological injury (neurological injury sub-study)	postoperative day 2	Perioperative trajectory of serum neurofilament light chain (NFL)
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	* acute coronary syndrome; * acute congestive heart failure (CHF); * coronary revascularization; * stroke; * new or progressive chronic kidney disease (CKD); * new need for renal replacement therapy (RRT); * all-cause mortality; * cardiovascular mortality

Trial Locations

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; 🇨🇭 St. Gallen, Switzerland