Individualized Versus Conventional Perioperative Blood Pressure Management

Not Applicable

Recruiting

• Conditions: Major Non-cardiac Surgery
• Interventions: Other: Individualized perioperative blood pressure management strategy; Other: Conventional perioperative blood pressure management strategy

• Registration Number: NCT06225453
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-24
• Study First Posted: 2024-01-26
• Study Start: 2024-01-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2026-08-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1896

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized strategy	Individualized perioperative blood pressure management strategy	Targeting mean arterial pressure and systolic blood pressure of ≥ -20% of their baseline values in each patient during surgery. The baseline values are defined as the average of all measurements between one day before surgery and the morning of the surgery. The target is 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 strategy is applied until the end of surgery. The target is applied until discharge from the post-anesthesia care unit. It the patient is transported to the intensive care unit after surgery, not the post-anesthesia care unit, then the strategy is applied until the end of surgery.
Conventional strategy	Conventional perioperative blood pressure management strategy	Targeting a mean arterial pressure of 65 mmHg or higher and a systolic blood pressure of 90 mmHg or higher during surgery. The target is 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 strategy is applied until the end of surgery.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event	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 Outcome Measures

Name	Time	Method
all-cause death	until discharge or postoperative day 7, whichever occurs first	death of any cause after surgery
myocardial infarction	until discharge or postoperative day 7, whichever occurs first	Diagnosed based on the Fourth Universal Definition of Myocardial Infarction (Type 1,2, and 3).
stroke	until discharge or postoperative day 7, whichever occurs first	a new ischemic or hemorrhagic cerebrovascular accident with a neurological deficit confirmed by brain imaging
new or worsening congestive heart failure	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.)
acute kidney injury	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.
Unplanned ICU admission	assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)	Unplanned intensive care unit admission after surgery
new-onset atrial fibrillation	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.
unplanned coronary revascularization	until discharge or postoperative day 7, whichever occurs first	percutaneous coronary intervention or bypass grafting, which was not an a priori planned stepwise procedure.
Length of postoperative hospital stay (days)	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

Trial Locations

Locations (5)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of