Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial
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).
Description
Qualifying patients will be randomized 1:1, with random-sized blocks, stratified by site. 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). Tight pressure management: In patients assigned to tight pressure management, angiotensin converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning of surgery. Other chronic antihypertensives will only be given as necessary to treat hypertension. Gen…
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. At least 45 years old; 2. Scheduled for major noncardiac surgery expected to last at least 2 hours; 3. Having general anesthesia, neuraxial anesthesia, or the combination; 4. Expected to require at least overnight hospitalization (planned ICU admission is acceptable); 5. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life); 6. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter; 7. Cared for by clinicians willing to follow the GUARDIAN protocol…
Interventions
- ProcedureTight blood pressure management
Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg.
- ProcedureRoutine 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 CenterOmaha, Nebraska
- Wake Forest UniversityWake Forest, North Carolina
- MetroHealth Medical CenterCleveland, Ohio
- Cleveland Clinic Fairview HospitalCleveland, Ohio
- Cleveland Clinic Main CampusCleveland, Ohio
- The University of Texas Health Science Center at HoustonHouston, Texas