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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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

⁃ Additional inclusion criteria for neurologic injury sub-study:

• Age ≥ 65 years

Locations
Other Locations
Switzerland
University Hospital Basel, Clinic for Anaesthesia, Intermediate Care, Prehospital Emergency Medicine and Pain Therapy
RECRUITING
Basel
Inselspital, Bern University Hospital, Department of Anaesthesiology and Pain Medicine
RECRUITING
Bern
Cantonal Hospital St. Gallen, Division of Perioperative Intensive Care Medicine
RECRUITING
Sankt Gallen
Contact Information
Primary
Patrick M Wanner, Dr. med.
patrick.wanner@usb.ch
+41 61 328 72 54
Backup
Luzius A Steiner, Prof. Dr. med.
luzius.steiner@usb.ch
+41 61 328 72 54
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2027-01
Participants
Target number of participants: 650
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov