The GUARDIAN Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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).
Eligibility
Primary outcome measure(s)
- Number of Participants with a Composite of Major Perfusion-Related Complications — During the initial 30 days after major non-cardiac surgery
The primary outcome is 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.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | Completed |
| Wake Forest University | Wake Forest | North Carolina | Completed |
| MetroHealth Medical Center | Cleveland | Ohio | Recruiting |
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | Completed |
| Cleveland Clinic Main Campus | Cleveland | Ohio | Completed |
| The University of Texas Health Science Center at Houston | Houston | Texas | Recruiting |
| Beijing Shijitan Hospital, Capital Medical University | Beijing | China | Recruiting |
| Peking Union Medical College Hospital | Beijing | China | Recruiting |
| Peking University First Hospital | Beijing | China | Recruiting |
| West China University Hospital | Chengdu | China | Recruiting |
| Prince of Wales Hospital, Chinese University of Hong Kong, Shatin | Hong Kong | China | Recruiting |
| Renji Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | China | Recruiting |
| Shanghai Chest Hospital | Shanghai | China | Recruiting |
| Shanghai Ninth People's Hospital | Shanghai | China | Recruiting |
| The Affiliated Lianyungang Hospital of Xuzhou Medical University | Xuzhou | China | Recruiting |
| University of Thessaly | Larissa | Greece | Completed |
| IRCCS Regina Elena National Cancer Institute | Rome | Italy | Recruiting |
| National Defense Medical College | Tokyo | Japan | Recruiting |
| Bakirkoy Dr. Sadi Konuk Research and Training Hospital | Bakırköy | Turkey (Türkiye) | Recruiting |
| Konya City Hospital | Konya | Turkey (Türkiye) | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04884802 on ClinicalTrials.gov ↗ ← All trials in Italy