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The GUARDIAN Trial
Sponsor: The University of Texas Health Science Center, Houston
Summary
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).
Official title: Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial
Key Details
Gender
All
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6254
Start Date
2021-07-25
Completion Date
2027-04-25
Last Updated
2025-08-29
Healthy Volunteers
No
Conditions
Interventions
Tight blood pressure management
Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.
Routine blood pressure management
ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.
Locations (20)
University of Nebraska Medical Center
Omaha, Nebraska, United States
Wake Forest University
Wake Forest, North Carolina, 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
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Beijing Shijitan Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
West China University Hospital
Chengdu, China
Prince of Wales Hospital, Chinese University of Hong Kong, Shatin
Hong Kong, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Ninth People's Hospital
Shanghai, China
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Xuzhou, China
University of Thessaly
Larissa, Greece
IRCCS Regina Elena National Cancer Institute
Rome, Italy
National Defense Medical College
Tokyo, Japan
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Bakırköy, Turkey (Türkiye)
Konya City Hospital
Konya, Turkey (Türkiye)