Individualized Versus Conventional Perioperative Blood Pressure Management
NCT06225453 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1896
Last updated 2025-05-28
Summary
Study objective: To compare the effect of different perioperative blood pressure management strategies on major postoperative adverse outcomes / Study design: a multicenter, randomized controlled trial / Participants: 1896 patients undergoing major non-cardiac surgery / 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).
Conditions
- Major Non-cardiac Surgery
Interventions
- OTHER
-
Individualized perioperative blood pressure management strategy
In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at no less than -20% of the baseline values of each patient.
- OTHER
-
Conventional perioperative blood pressure management strategy
In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients.
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Karam nam, M.D., Ph.D. · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-29
- Primary Completion
- 2026-08-31
- Completion
- 2026-09-30
Countries
- South Korea
Study Locations
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