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NCT Number: NCT06225453

Individualized Versus Conventional Perioperative Blood Pressure Management

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).

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Key information

Conditions

Major Non-cardiac Surgery

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Seongnam, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Individualized perioperative blood pressure management strategy

Other

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.

Conventional perioperative blood pressure management strategy

Other

In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients.

Primary outcomes

  1. The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event

    Time frame: Occuring until discharge or postoperative day 7, whichever occurs first

    A composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury.

Secondary outcomes

  1. all-cause death

    Time frame: until discharge or postoperative day 7, whichever occurs first

    death of any cause after surgery

  2. stroke

    Time frame: until discharge or postoperative day 7, whichever occurs first

    a new ischemic or hemorrhagic cerebrovascular accident with a neurological deficit confirmed by brain imaging

  3. myocardial infarction

    Time frame: until discharge or postoperative day 7, whichever occurs first

    Diagnosed based on the Fourth Universal Definition of Myocardial Infarction (Type 1,2, and 3).

  4. new or worsening congestive heart failure

    Time frame: until discharge or postoperative day 7, whichever occurs first

    Congestive heart failure: diagnosis on discharge letter or progression notes (medical records: pulmonary edema, congestive heart failure, etc.)

  5. unplanned coronary revascularization

    Time frame: until discharge or postoperative day 7, whichever occurs first

    percutaneous coronary intervention or bypass grafting, which was not an a priori planned stepwise procedure.

  6. acute kidney injury

    Time frame: until discharge or postoperative day 7, whichever occurs first

    Defined based on the serum creatinine criteria of the Kidney Disease: Improving Global Outcomes (KDIGO).

    A. Increase in serum creatinine level by 0.3 mg/dl or more within 48 hours, or B. Increase in serum creatinine level to 1.5 times the baseline or more within 7 days.

    The baseline serum creatinine level was defined as the most recent value measured prior to surgery.

  7. Length of postoperative hospital stay (days)

    Time frame: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)

    Length of postoperative hospital stay described in days

  8. Unplanned ICU admission

    Time frame: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)

    Unplanned intensive care unit admission after surgery

  9. new-onset atrial fibrillation

    Time frame: until discharge or postoperative day 7, whichever occurs first

    New-onset atrial fibrillation of any duration captured on 12-lead electrocardiogram, continuous electrocardiogram monitoring, or telemetry.

Study contacts

Contact information is provided by the study sponsor or research team.

Karam Nam, M.D., Ph.D.

CONTACT

[email protected]

82-2-2072-0643

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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