Individualized Versus Conventional Perioperative Blood Pressure Management

NCT06225453 | Recruiting

• 1 other identifier: SPROUT-4
• Study Type: interventional
• Target: 1,896
• Locations: 1 country
• Sites: 5

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).

Conditions

Major Non-cardiac Surgery

Outcome Measures

Primary Outcomes (1)

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

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

  Occuring until discharge or postoperative day 7, whichever occurs first

Secondary Outcomes (9)

• all-cause death

  until discharge or postoperative day 7, whichever occurs first

• stroke

  until discharge or postoperative day 7, whichever occurs first

• myocardial infarction

  until discharge or postoperative day 7, whichever occurs first

• new or worsening congestive heart failure

  until discharge or postoperative day 7, whichever occurs first

• unplanned coronary revascularization

  until discharge or postoperative day 7, whichever occurs first

Study Arms (2)

Individualized strategy

EXPERIMENTAL

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.

Other: Individualized perioperative blood pressure management strategy

Conventional strategy

ACTIVE COMPARATOR

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.

Other: Conventional perioperative blood pressure management strategy

Interventions

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.

Individualized strategy

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.

Conventional strategy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39725988 DERIVED

Study Officials

• Karam nam, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82-2-2072-0643; karamnam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 26, 2024
• Study Start: January 29, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)