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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

Inclusion Criteria24

  • 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)
  • 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
  • Age ≥ 65 years

Exclusion Criteria6

  • 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
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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