Major Non-cardiac SurgeryNCT06225453
Individualized Versus Conventional Perioperative Blood Pressure Management
A study testing Individualized perioperative blood pressure management strategy and Conventional perioperative blood pressure management strategy in people with Major Non-cardiac Surgery, run by Seoul National University Hospital at 5 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Major Non-cardiac Surgery
- What is being tested?
- Individualized perioperative blood pressure management strategy and Conventional perioperative blood pressure management strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,896 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 29 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul, 03080
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Ajou University Hospital
Suwon
About this study
Official title: Effect of Individualized Versus Conventional Blood Pressure Management on Major Adverse Cardiac, Cerebrovascular, and Renal Events After Major Non-cardiac Surgery: Multicenter, Randomized Controlled Trial
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).
Read the 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
- Being tested
- Individualized perioperative blood pressure management strategy, Conventional perioperative blood pressure management strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized perioperative blood pressure management strategyOther
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 perioperative blood pressure management strategyOther
In this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional perioperative blood pressure management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Occuring until discharge or postoperative day 7, whichever occurs first
Secondary outcomes (9)
all-cause death
death of any cause after surgery
Measured: until discharge or postoperative day 7, whichever occurs first
stroke
a new ischemic or hemorrhagic cerebrovascular accident with a neurological deficit confirmed by brain imaging
Measured: until discharge or postoperative day 7, whichever occurs first
myocardial infarction
Diagnosed based on the Fourth Universal Definition of Myocardial Infarction (Type 1,2, and 3).
Measured: until discharge or postoperative day 7, whichever occurs first
new or worsening congestive heart failure
Congestive heart failure: diagnosis on discharge letter or progression notes (medical records: pulmonary edema, congestive heart failure, etc.)
Measured: until discharge or postoperative day 7, whichever occurs first
unplanned coronary revascularization
percutaneous coronary intervention or bypass grafting, which was not an a priori planned stepwise procedure.
Measured: until discharge or postoperative day 7, whichever occurs first
acute kidney injury
Defined based on the serum creatinine criteria of the Kidney Disease: Improving Global Outcomes (KDIGO).
- 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.
Measured: until discharge or postoperative day 7, whichever occurs first
Length of postoperative hospital stay (days)
Length of postoperative hospital stay described in days
Measured: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
Unplanned ICU admission
Unplanned intensive care unit admission after surgery
Measured: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
new-onset atrial fibrillation
New-onset atrial fibrillation of any duration captured on 12-lead electrocardiogram, continuous electrocardiogram monitoring, or telemetry.
Measured: until discharge or postoperative day 7, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start29 Jan 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Non-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,896 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Nam, MD, Seoul National University Hospital
- Investigators
- Karam nam, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225453
- Sponsor's protocol ID
- SPROUT-4
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39725988
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individualized Versus Conventional Blood Pressure Management on Major Adverse Cardiac, Cerebrovascular, and Renal Events After Major Non-cardiac Surgery: Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06225453
- Acronym / sponsor ID
- SPROUT-4
- Conditions
- Major Non-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,896 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized strategy | Experimental | Other: Individualized perioperative blood pressure management strategyTargeting 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 | Active comparator | Other: Conventional perioperative blood pressure management strategyTargeting 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- Emergency surgery
- Organ transplantation surgery
- Brain/carotid artery surgery
- American Society of Anesthesiologists physical status 5 or 6
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized perioperative blood pressure management strategyIn this group, perioperative mean arterial pressure and systolic blood pressure are maintained at no less than -20% of the baseline values of each patient. | Other | Individualized strategy |
| Conventional perioperative blood pressure management strategyIn this group, perioperative mean arterial pressure and systolic blood pressure are maintained at ≥65 mmHg and ≥90 mmHg, respectively, in all patients. | Other | Conventional strategy |
Primary outcome
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event
Time frame: 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.
9 secondary outcomes
all-cause death
Time frame: until discharge or postoperative day 7, whichever occurs first
stroke
Time frame: until discharge or postoperative day 7, whichever occurs first
myocardial infarction
Time frame: until discharge or postoperative day 7, whichever occurs first
new or worsening congestive heart failure
Time frame: until discharge or postoperative day 7, whichever occurs first
unplanned coronary revascularization
Time frame: until discharge or postoperative day 7, whichever occurs first
acute kidney injury
Time frame: until discharge or postoperative day 7, whichever occurs first
Length of postoperative hospital stay (days)
Time frame: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
Unplanned ICU admission
Time frame: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
new-onset atrial fibrillation
Time frame: until discharge or postoperative day 7, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 39725988Chung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karam nam, M.D., Ph.D. principal investigator
Seoul National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized perioperative blood pressure management strategy and Conventional perioperative blood pressure management strategy in people with Major Non-cardiac Surgery, run by Seoul National University Hospital at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event (time frame: Occuring until discharge or postoperative day 7, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06225453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.