The GUARDIAN Trial

Not Applicable

Recruiting

• Conditions: Blood Pressure

• Registration Number: NCT04884802
• Lead Sponsor: The Cleveland Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 6254

Inclusion Criteria

Inclusion Criteria:<br><br> - =45 years old<br><br> - Scheduled for major noncardiac surgery expected to last at least 2 hours;<br><br> - Having general endotracheal, neuraxial anesthesia, or the combination;<br><br> - Expected to require at least overnight hospitalization;<br><br> - Are designated ASA physical status 2-4 (ranging from mild systemic disease through<br> severe systemic disease that is a constant threat to life);<br><br> - Chronically taking at least one anti-hypertensive medication;<br><br> - Expected to have direct blood pressure monitoring with an arterial catheter;<br><br> - Cared for by clinicians willing to follow the GUARDIAN protocol;<br><br> - Subject to at least one of the following risk factors:<br><br> - History of peripheral arterial disease;<br><br> - History of coronary artery disease;<br><br> - History of stroke or transient ischemic attack;<br><br> - Serum creatinine >175 µmol/L (>2.0 mg/dl);<br><br> - Diabetes requiring medication;<br><br> - Current smoking or 15 pack-year history of smoking tobacco;<br><br> - Scheduled for major vascular surgery;<br><br> - Body mass index =35 kg/m2;<br><br> - Preoperative high-sensitivity troponin T >14 ng/L or troponin I equivalent; defined<br> as =15 ng/L (Abbott assay),73 19 ng/L (Siemens assay, [Borges, unpublished]), or 50%<br> of the 99% percentile for other assays; B-type natriuretic protein (BNP) >80 ng/L or<br> N-terminal B-type natriuretic protein (NT-ProBNP) >200 ng/L<br><br>Exclusion Criteria:<br><br> - Are scheduled for carotid artery surgery;<br><br> - Are scheduled for intracranial surgery;<br><br> - Are scheduled for partial or complete nephrectomy;<br><br> - Are scheduled for pheochromocytoma surgery;<br><br> - Are scheduled for liver or kidney transplantation;<br><br> - Require preoperative intravenous vasoactive medications;<br><br> - Have a condition that precludes routine or tight blood pressure management such as<br> surgeon request for relative hypotension;<br><br> - Require beach-chair positioning;<br><br> - Have a documented history of dementia;<br><br> - Have language, vision, or hearing impairments that may compromise cognitive<br> assessments;<br><br> - Have contraindications to norepinephrine or phenylephrine per clinician judgement;<br><br> - Have previously participated in the GUARDIAN trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of major perfusion-related complications

Secondary Outcome Measures

Name	Time	Method
Postoperative delirium;Major adverse cardiac events;Cognition