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RECRUITING
NCT04884802
NA

The GUARDIAN Trial

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

PROCEDURE

Tight blood pressure management

Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.

PROCEDURE

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)