Individualized Versus Conventional Perioperative Blood Pressure Management
Recruiting now · Not applicable
Conditions studied: Major Non-cardiac Surgery
In brief
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).
Key facts
- Study ID
- NCT06225453
- Run by
- Seoul National University Hospital
- People needed
- 1896
- Starts
- 2024-01-29
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-07
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Emergency surgery
- Organ transplantation surgery
- Brain/carotid artery surgery
- American Society of Anesthesiologists physical status 5 or 6
- Pregnancy
- Uncontrolled preoperative hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
- Estimated glomerular filtration rate <30 ml/min/1.73m2
- Renal replacement therapy
- Acute decompensated heart failure
- Sepsis
- Shock
- Use of inotropes/vasopressor infusion (dopamine, norepinephrine, vasopressin, etc.)
Where it is running
- Seoul National University Bundang Hospital — Seongnam, South Korea (enrolling)
- Seoul National University Hospital — Seoul, South Korea (enrolling)
- Korea University Guro Hospital — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Ajou University Hospital — Suwon, South Korea (enrolling)
Full record on ClinicalTrials.gov
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