NCT06225453

Individualized Versus Conventional Perioperative Blood Pressure Management

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,896 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study, aiming to reflect real clinical scenarios as much as possible, does not impose specific restrictions on perioperative management other than the target blood pressure. It allows discretion to each participating institution or physician. For the same reason, there are no restrictions on method for blood pressure measurement (invasive, non-invasive, or both), site of blood pressure measurement, fluid therapy, and vasopressors use for maintaining target blood pressure in each group. Through random allocation, the conventional group targets a mean arterial pressure (MAP) of 65 mmHg or higher and a systolic blood pressure (SBP) of 90 mmHg or higher during surgery. The individualized group targets no less than a -20% of the baseline MAP and SBP. The baseline MAP and SBP are defined as the average values of all MAP and SBP measured between one day before surgery and the morning of the surgery. The two blood pressure management strategies are 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 blood pressure management strategies are applied until the end of surgery.

Conditions

• Major Non-cardiac Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-29
• Primary completion: 2026-08-31
• Completion: 2026-09-30
• First posted: 2024-01-26
• Last updated: 2025-05-28

Locations

5 sites across 1 country: South Korea