Individualized Versus Conventional Perioperative Blood Pressure Management

Seoul National University

Status: Enrolling

Conditions: Major Non-cardiac Surgery

Treatments: Other: Individualized perioperative blood pressure management strategy; Other: Conventional perioperative blood pressure management strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT06225453

SPROUT-4

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,896 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,896 participants in 2 patient groups

Individualized strategy

Experimental group

Description:

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.

Treatment:

Other: Individualized perioperative blood pressure management strategy

Conventional strategy

Active Comparator group

Description:

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.

Treatment:

Other: Conventional perioperative blood pressure management strategy