The GUARDIAN Trial

Recruiting now · Not applicable

Conditions studied: Blood Pressure

In brief

An international randomized trial to test the primary hypothesis that perioperative tight blood pressure management reduces a composite of major perfusion-related complications (myocardial injury, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, deep or organ-space infection, sepsis, and death) in the 30 days after major non-cardiac surgery. The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).

Key facts

Study ID

NCT04884802

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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays - all within 6 months;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

• Konya City Hospital — Konya, Turkey (Türkiye) (enrolling)
• Shanghai Ninth People's Hospital — Shanghai, China (enrolling)
• The Affiliated Lianyungang Hospital of Xuzhou Medical University — Xuzhou, China (enrolling)
• IRCCS Regina Elena National Cancer Institute — Rome, Italy (enrolling)
• National Defense Medical College — Tokyo, Japan (enrolling)
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital — Bakırköy, Turkey (Türkiye) (enrolling)
• MetroHealth Medical Center — Cleveland, Ohio, United States (enrolling)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
• Beijing Shijitan Hospital, Capital Medical University — Beijing, China (enrolling)
• Peking Union Medical College Hospital — Beijing, China (enrolling)
• Peking University First Hospital — Beijing, China (enrolling)
• West China University Hospital — Chengdu, China (enrolling)
• Prince of Wales Hospital, Chinese University of Hong Kong, Shatin — Hong Kong, China (enrolling)
• Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (enrolling)
• Shanghai Chest Hospital — Shanghai, China (enrolling)
• Wake Forest University — Wake Forest, North Carolina, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States
• Cleveland Clinic Main Campus — Cleveland, Ohio, United States
• University of Thessaly — Larissa, Greece

Full record on ClinicalTrials.gov

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