The GUARDIAN Trial - Vasopressor Sub-Study

Enrolling by invitation · Phase 4

Conditions studied: Blood Pressure

In brief

This is a sub-study of the overall GUARDIAN trial (NCT04884802) in which some GUARDIAN trial participants will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Key facts

Study ID

NCT04934748

Run by

The University of Texas Health Science Center, Houston

People needed

6254

Starts

2021-07-25

Expected to finish

2027-04-25

Last updated by the study team

2025-08-29

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 45 years old;
• Scheduled for major noncardiac surgery expected to last at least 2 hours;
• Having general anesthesia, neuraxial anesthesia, or the combination;
• Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
• Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
• Expected to have direct intraoperative 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:
• Age >65 years;
• History of peripheral arterial disease;
• History of coronary artery disease;
• History of stroke or transient ischemic attack;
• Serum creatinine >175 μmol/L (>2.0 mg/dl) within 6 months;
• 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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays - all within 6 months;
• B-type natriuretic protein (BNP) >80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) >200 ng/L within six months.

You may not qualify if…

• 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 or kidney 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 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 the GUARDIAN trial.

Where it is running

• University of Nebraska Medical Center — Omaha, Nebraska, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• Beijing Shijitan Hospital, Capital Medical University — Beijing, China
• Peking Union Medical College Hospital — Beijing, China
• Shanghai Ninth People's Hospital — Shanghai, China
• Shanghai Chest Hospital — Shanghai, China
• West China Hospital — Sichuan, China
• University of Thessaly — Larissa, Greece
• National Defense College — Tokyo, Japan

Full record on ClinicalTrials.gov

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