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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause death | death of any cause after surgery | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karam Nam, M.D., Ph.D. | Contact | 82-2-2072-0643 | karamnam@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Karam nam, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39725988 | Derived | 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. |
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| 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. |
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| 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). | 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.) | 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. | 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). A. 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. | until discharge or postoperative day 7, whichever occurs first |
| Length of postoperative hospital stay (days) | Length of postoperative hospital stay described in days | 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 | 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. | until discharge or postoperative day 7, whichever occurs first |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Ajou University Hospital | Recruiting | Suwon | South Korea |
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