Clinical trial NCT06225453: Individualized Versus Conventional Perioperative Blood Pressure Management
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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Non-cardiac Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 1896
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: The incidence of postoperative major adverse cardiac, cerebrovascular, and renal event
timeFrame: Occuring until discharge or postoperative day 7, whichever occurs first
Secondary outcomes:
measure: all-cause death
timeFrame: until discharge or postoperative day 7, whichever occurs first
measure: stroke
timeFrame: until discharge or postoperative day 7, whichever occurs first
measure: myocardial infarction
timeFrame: until discharge or postoperative day 7, whichever occurs first
measure: new or worsening congestive heart failure
timeFrame: until discharge or postoperative day 7, whichever occurs first
measure: unplanned coronary revascularization
timeFrame: until discharge or postoperative day 7, whichever occurs first
measure: acute kidney injury
timeFrame: until discharge or postoperative day 7, whichever occurs first
measure: Length of postoperative hospital stay (days)
timeFrame: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
measure: Unplanned ICU admission
timeFrame: assessed from the end of surgery to hospital discharge (through study completion, generally of under one month)
measure: new-onset atrial fibrillation
timeFrame: until discharge or postoperative day 7, whichever occurs first
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Karam nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: