Actively Recruiting
The GUARDIAN Trial
Led by The University of Texas Health Science Center, Houston · Updated on 2025-08-29
6254
Participants Needed
20
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The GUARDIAN Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 45 years old
- Scheduled for major noncardiac surgery expected to last at least 2 hours
- Receiving general anesthesia, neuraxial anesthesia, or both
- Expected overnight hospitalization (planned ICU admission acceptable)
- ASA physical status 2-4 (mild to severe systemic disease)
- Expected direct intraoperative blood pressure monitoring with arterial catheter
- Care by clinicians willing to follow the GUARDIAN protocol
- Has at least one risk factor: age >65, peripheral arterial disease, coronary artery disease, stroke or transient ischemic attack, serum creatinine >175 bcmol/L within 6 months, diabetes requiring medication, current or 15 pack-year smoking history, scheduled major vascular surgery, BMI 135 kg/m2, elevated troponin within 6 months, or elevated BNP/NT-ProBNP within 6 months
You will not qualify if you...
- Scheduled for carotid artery surgery
- Scheduled for intracranial surgery
- Scheduled for partial or complete nephrectomy
- Scheduled for pheochromocytoma surgery
- Scheduled for liver or kidney transplantation
- Require preoperative intravenous vasoactive medications
- Condition precluding routine or tight blood pressure management such as surgeon request for relative hypotension
- Require beach-chair positioning
- Documented history of dementia
- Language, vision, or hearing impairments that may affect cognitive assessments
- Contraindications to norepinephrine or phenylephrine as judged by clinician
- Previous participation in the GUARDIAN trial
AI-Screening
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Trial Site Locations
Total: 20 locations
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Completed
2
Wake Forest University
Wake Forest, North Carolina, United States, 27106
Completed
3
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
4
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
Completed
5
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Completed
6
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
7
Beijing Shijitan Hospital, Capital Medical University
Beijing, China
Actively Recruiting
8
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
9
Peking University First Hospital
Beijing, China
Actively Recruiting
10
West China University Hospital
Chengdu, China
Actively Recruiting
11
Prince of Wales Hospital, Chinese University of Hong Kong, Shatin
Hong Kong, China
Actively Recruiting
12
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Actively Recruiting
13
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
14
Shanghai Ninth People's Hospital
Shanghai, China
Actively Recruiting
15
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Xuzhou, China
Actively Recruiting
16
University of Thessaly
Larissa, Greece
Completed
17
IRCCS Regina Elena National Cancer Institute
Rome, Italy
Actively Recruiting
18
National Defense Medical College
Tokyo, Japan
Actively Recruiting
19
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Bakırköy, Turkey (Türkiye)
Actively Recruiting
20
Konya City Hospital
Konya, Turkey (Türkiye)
Actively Recruiting
Research Team
V
Valerie L. Anderson, BS
CONTACT
D
Daniel Sessler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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