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ACTIVE NOT RECRUITING

NCT04789733

The GUARDIAN Pilot Trial

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management).

Official title: Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Pilot Trial

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-04-27

Completion Date

2026-12-31

Last Updated

2026-03-17

Healthy Volunteers

Conditions

General Surgery

Interventions

OTHER

Tight pressure management

Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management)

OTHER

Routine pressure management

Routine intraoperative blood pressure management and immediate restart of antihypertensive medications.

Inclusion Criteria: * ≥45 years old * Scheduled for major noncardiac surgery expected to last at least 2 hours; * Having general endotracheal, neuraxial anesthesia, or the combination; * Expected to require at least overnight hospitalization; * Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life); * Chronically taking at least one anti-hypertensive medication; * Expected to have direct blood pressure monitoring with an arterial catheter; * Cared for by clinicians willing to follow the GUARDIAN protocol; * Subject to at least one of the following risk factors: * History of peripheral arterial surgery; * History of coronary artery disease; * History of stroke or transient ischemic attack; * Serum creatinine \>175 µmol/L (\>2.0 mg/dl); * Diabetes requiring medication; * Current smoking or 15 pack-year history of smoking tobacco; * Scheduled for major vascular surgery; * Body mass index ≥35 kg/m2; * Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent; * B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) \>100 ng/L Exclusion Criteria: * Are scheduled for carotid artery surgery; * Are scheduled for intracranial surgery; * Are scheduled for partial or complete nephrectomy; * Are scheduled for pheochromocytoma surgery; * Are scheduled for liver transplantation; * Require preoperative intravenous vasoactive medications; * Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension; * Require beach-chair positioning; * Have end-stage renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) \<30 ml/min; * Have a documented history of dementia; * Have language, vision, or hearing impairments that may compromise cognitive assessments; * Have contraindications to norepinephrine or phenylephrine per clinician judgement; * Have previously participated in this trial.

Locations (1)

China Japan Union Hospital of Jilin University

Changchun, Jilin, China