Actively Recruiting

Age: 45Years +
All Genders
NCT05336864

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

Led by University Hospital, Basel, Switzerland · Updated on 2025-07-17

650

Participants Needed

3

Research Sites

241 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing major noncardiac surgery under general anesthesia, including vascular surgery (except arteriovenous shunt, vein stripping, carotid endarterectomies), intraperitoneal, intrathoracic, or major orthopedic surgery
  • At cardiovascular risk by meeting at least one of these: NT-proBNP ≥ 200 ng/l, history of coronary artery disease, peripheral vascular disease, stroke, major vascular surgery (except excluded types), or at least three of the following: major surgery type, history of heart failure or pulmonary edema, transient ischemic attack, diabetes treated with medication, age over 70 years, history of hypertension, serum creatinine > 175 mcmol/l or creatinine clearance < 60 l/min/1.73m2, smoking within 2 years
  • Intraoperative continuous invasive blood pressure monitoring is planned
  • Surgery planned for at least 90 minutes
  • Planned postoperative hospital stay of at least one night
  • For neurologic injury substudy: age 65 years or older
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Emergency surgery
  • Urological surgery
  • Severe kidney failure with creatinine clearance less than 30 ml/min or dialysis
  • Participation in interventional trials with overlapping endpoints, except possible inclusion in colchicine trial subset
  • Previously enrolled in this study

AI-Screening

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Trial Site Locations

Total: 3 locations

1

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

Basel, Switzerland, 4031

Actively Recruiting

2

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

Bern, Switzerland, 3010

Actively Recruiting

3

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

Sankt Gallen, Switzerland, 9007

Actively Recruiting

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Research Team

P

Patrick M Wanner, Dr. med.

CONTACT

L

Luzius A Steiner, Prof. Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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