RecruitingNot ApplicableNCT06225453

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


Sponsor

Seoul National University Hospital

Enrollment

1,896 participants

Start Date

Jan 29, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 45 Years

Inclusion Criteria3

  • 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 Criteria12

  • 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.)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERIndividualized 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.

OTHERConventional 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.


Locations(5)

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06225453