Individualized Versus Conventional Perioperative Blood Pressure Management

Major Non-cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225453
• Other study ID #: SPROUT-4
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: March 2024
• Source: Seoul National University Hospital
• Contact: Karam Nam, M.D., Ph.D.
• Phone: 82-2-2072-0643
• Email: karamnam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1896
• Est. completion date: September 30, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Major Non-cardiac Surgery

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	all-cause death	death of any cause after surgery	until discharge or postoperative day 7, whichever occurs first
Secondary	stroke	a new ischemic or hemorrhagic cerebrovascular accident with a neurological deficit confirmed by brain imaging	until discharge or postoperative day 7, whichever occurs first
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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