Individualized Versus Conventional Perioperative Blood Pressure Management

NCT ID: NCT06225453

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1896 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2026-09-30

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.

Conditions

Major Non-cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Individualized 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.

Group Type: EXPERIMENTAL

Individualized perioperative blood pressure management strategy

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Conventional perioperative blood pressure management strategy

Intervention Type: OTHER

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

Interventions

Individualized 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.

Intervention Type: OTHER

Conventional 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.

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karam Nam, MD

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karam nam, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status: RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Ajou University Hospital

Suwon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

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

Role: CONTACT

karamnam@gmail.com

82-2-2072-0643

Facility Contacts

Chang-Hoon Koo

Role: primary

Jae-Woo Ju, M.D.

Role: primary

Hye-Bin Kim

Role: primary

Jungchan Park

Role: primary

Ha Yeon Kim

Role: primary

References

Chung J, Koo CH, Park J, Kim HB, Bae J, Ju JW, Lee S, Oh AR, Kim HS, Park SJ, Jeon Y, Nam K; Seoul PeRioperative OUTcome research-4 (SPROUT-4) Investigators. Effect of individualized versus conventional perioperative blood pressure management on postoperative major complications in high-risk patients undergoing noncardiac surgery: study protocol for the SPROUT-4 multicenter randomized controlled trial. Trials. 2024 Dec 26;25(1):850. doi: 10.1186/s13063-024-08707-4.

Reference Type: DERIVED

PMID: 39725988 (View on PubMed)

Other Identifiers

SPROUT-4

Identifier Type: -

Identifier Source: org_study_id