Effect of Individualized Versus Conventional Blood Pressure Management on Major Adverse Cardiac, Cerebrovascular, and Renal Events After Major Non-cardiac Surgery: Multicenter, Randomized Controlled Trial
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Methods: Patients are randomized into two groups, the individualized strategy (maintaining perioperative mean arterial pressure and systolic blood pressure more than -20% of their baseline values) or the conventional strategy (maintaining perioperative mean arterial pressure ≥65 mmHg and systolic blood pressure ≥90 mmHg in all patients). Then, the frequency of major postoperative adverse outcomes occurring within 7 postoperative days or before discharge (whichever occurs first). / Primary outcome: a composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury, occuring within 7 postoperative days or before discharge (whichever occurs first).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:
• Patients aged ≥65 or,
• those aged ≥45 with a history of coronary artery disease, peripheral vascular disease, transient ischemic attack/stroke, or congestive heart failure,
• undergoing non-cardiac surgery under general anesthesia with an anticipated duration of ≥2 hours.
Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Contact Information
Primary
Karam Nam, M.D., Ph.D.
karamnam@gmail.com
82-2-2072-0643
Time Frame
Start Date:2024-01-29
Estimated Completion Date:2026-09-30
Participants
Target number of participants:1896
Treatments
Experimental: Individualized strategy
Targeting mean arterial pressure and systolic blood pressure of ≥ -20% of their baseline values in each patient during surgery. The baseline values are defined as the average of all measurements between one day before surgery and the morning of the surgery. The target is applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.~The target is applied until discharge from the post-anesthesia care unit. It the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.
Active_comparator: Conventional strategy
Targeting a mean arterial pressure of 65 mmHg or higher and a systolic blood pressure of 90 mmHg or higher during surgery. The target is applied until discharge from the post-anesthesia care unit. If the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.