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Intraoperative Arterial HypotensionAR-NONCARDIACNCT05336864

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

An observational study of Intraoperative Arterial Hypotension, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Intraoperative Arterial Hypotension
What is being tested?
Non-invasive cerebral oximetry monitoring, additional perioperative blood sampling and clinical & telephone assessments
How many people
650 participants
Where
3 sitesSwitzerland
Study dates
20 May 2022to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
Show all 25Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Switzerland3 sites

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

    Basel, 4031

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

    Bern, 3010

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

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Non-invasive cerebral oximetry monitoring, additional perioperative blood sampling, clinical & telephone assessments, Non-invasive somatic oximetry monitoring, Processed electroencephalogram (pEEG) monitoring
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)
Medical subject headings
Hypotension, Trauma, Nervous System, Charcot-Marie-Tooth disease, Type 1F

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-invasive cerebral oximetry monitoringOther

    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 samplingOther

    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 assessmentsOther

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

  • Non-invasive somatic oximetry monitoringOther

    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) monitoringOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    • 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
    • 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%)

    Measured: postoperative days 1-3

Secondary outcomes (2)

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

    • 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

    Measured: up to 1 year following surgery

  2. Neurological injury (neurological injury sub-study)

    Perioperative trajectory of serum neurofilament light chain (NFL)

    Measured: postoperative day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start20 May 2022
  3. Primary completion29 Jan 2026
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05336864
Sponsor's protocol ID
2022-00298; am22Wanner
Acronym
AR-NONCARDIAC
Status last verified
May 2026
First submitted
13 Apr 2022
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wanner PM, Schindler C, Beqiri E, Smielewski P, Hogue CW, Brown CH 4th, Jeon Y, Puelacher C, Murgatroyd Wiles AJ, Yurttas T, Burgi J, Seeberger E, Doyle N, Klein C, Korte W, Pietsch U, Vogt AP, Filipovic M, Steiner LA. Clinical implications and feasibility of cerebral autoregulation-based precision blood pressure monitoring in major noncardiac surgery: A protocol for AUTOREGULATE-NONCARDIAC, a multicentre prospective cohort study and peri-operative precision medicine platform. Eur J Anaesthesiol Intensive Care. 2025 Dec 5;5(1):e0093. doi: 10.1097/EA9.0000000000000093. eCollection 2026 Feb.

    PubMed 41684415

  • D'Amico F, Turi S, Landoni G. Intraoperative hypotension and postoperative outcomes: just the tip of the iceberg. Response to Br J Anaesth 2024; 132: 804-5. Br J Anaesth. 2024 Jul;133(1):207. doi: 10.1016/j.bja.2024.04.008. Epub 2024 May 2. No abstract available.

    PubMed 38702240

Questions about this trial

What is this clinical trial studying?

An observational study of Intraoperative Arterial Hypotension, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative organ injury on postoperative days 1-3, a composite of: (time frame: postoperative days 1-3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05336864, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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