Individualized Versus Conventional Perioperative Blood Pressure Management
South Korea1,896 participantsStarted 2024-01-29
Plain-language 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).
Who can participate
Age range
45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event
Timeframe: Occuring until discharge or postoperative day 7, whichever occurs first