Individualized Versus Conventional Perioperative Blood Pressure Management

Phase

N/A

Condition

N/A

Treatment

Conventional perioperative blood pressure management strategy

Individualized perioperative blood pressure management strategy

Clinical Study ID

NCT06225453

SPROUT-4

Ages > 45
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Patients aged ≥65 or,
those aged ≥45 with a history of coronary artery disease, peripheral vasculardisease, transient ischemic attack/stroke, or congestive heart failure,
undergoing non-cardiac surgery under general anesthesia with an anticipated durationof ≥2 hours.

Exclusion

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 ordiastolic 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.)

Study Design

Conventional perioperative blood pressure management strategy

January 29, 2024

September 30, 2026

Study 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.

Connect with a study center

Seoul National University Bundang Hospital
Seongnam,
Korea, Republic of
Active - Recruiting
Korea University Guro Hospital
Seoul,
Korea, Republic of
Active - Recruiting
Samsung Medical Center
Seoul,
Korea, Republic of
Active - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic of
Active - Recruiting
Ajou University Hospital
Suwon,
Korea, Republic of
Active - Recruiting

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