personalized blood pressure management on postoperative complications and mortality in high-risk patients undergoing major non-cardiac surgery (premium)

Conditions: Hypotension

Summary: high-risk populations, particularly elderly individuals and patients with cardiovascular comorbidities, exhibit markedly elevated incidences of postoperative myocardial injury (mins), acute kidney injury (aki), and mortality. intraoperative hypotension (ioh), a pervasive clinical phenomenon affecting 40%-90% of surgical cases, substantial observational evidence links ioh severity/duration to ischemic organ injuries (mins, aki) and long-term morbidity.nevertheless, inherent limitations of observational designs-particularly residual confounding-preclude definitive causal inferences. notably, randomized controlled trials (rcts) investigating goal-directed hemodynamic interventions demonstrate inconsistent clinical benefits, underscoring the imperative to clarify causal mechanisms between ioh and organ injury. this causal ambiguity arises from two unresolved scientific questions: (1) threshold personalization deficit; (2) therapeutic strategy limitations. in light of current evidence, perioperative hypotension management demands personalized strategies, the investigators propose a multicenter randomized controlled trial (rct) that aims to clarify the clinical benefits of individualized blood pressure management.

anesthesia- and surgery-related complications and mortality constitute a critical global public health burden. annually, over 300 million surgical procedures are performed worldwide, with postoperative complications and mortality standing as predominant contributors to adverse outcomes. high-risk populations, particularly elderly individuals and patients with cardiovascular comorbidities, exhibit markedly elevated incidences of postoperative myocardial injury (mins), acute kidney injury (aki), and mortality. refinement of perioperative management protocols-especially precision-guided hemodynamic control-has emerged as a pivotal strategy for optimizing patient prognosis. intraoperative hypotension (ioh), a pervasive clinical phenomenon affecting 40%-90% of surgical cases, is conventionally defined through either absolute thresholds (e.g., systolic blood pressure (sbp) \ 20% decline). its high prevalence and association with end-organ hypoperfusion have positioned ioh as a central concern in perioperative care. substantial observational evidence links ioh severity/duration to ischemic organ injuries (mins, aki) and long-term morbidity. nevertheless, inherent limitations of observational designs-particularly residual confounding-preclude definitive causal inferences. notably, randomized controlled trials (rcts) investigating goal-directed hemodynamic interventions demonstrate inconsistent clinical benefits, underscoring the imperative to clarify causal mechanisms between ioh and organ injury. this causal ambiguity arises from two unresolved scientific questions: 1. threshold personalization deficit: current paradigms predominantly apply population-based fixed thresholds (e.g., map ≥75-80 mmhg vs. ≥60 mmhg), disregarding interindividual hemodynamic variability. although the intraoperative norepinephrine to control arterial pressure (inpress) study used personalized blood pressure targets, its approach of measuring baseline blood pressure during a single clinic visit conflicts with current evidence. research shows that 24-hour ambulatory monitoring is the most reliable method to capture an individual's true baseline blood pressure and daily fluctuations. 2. therapeutic strategy limitations: conventional protocols emphasizing aggressive vasopressor use to achieve arbitrary pressure targets may inadvertently increase complications like anastomotic leakage and aki. furthermore, the multifactorial etiology of ioh-encompassing hypovolemia, vasoplegia, and impaired cardiac contractility-demands etiology-specific management algorithms rather than universal interventions. in light of current evidence, perioperative hypotension management demands personalized strategies. to address this need, the investigators propose a multicenter randomized controlled trial (rct) that pioneers the integration of ambulatory blood pressure monitoring (abpm) with etiology-specific intervention protocols. this study aims to clarify the clinical benefits of individualized blood pressure management and establish high-quality evidence to advance precision anesthesia practices in perioperative care.

Eligibility criteria:
inclusion criteria: * aged 65-90 yr; * scheduled to undergo elective non-cardiac major surgery under general anesthesia (with an estimated surgery duration of ≥ 2 hours and an anticipated postoperative hospital stay of ≥ 2 days); * patients with high cardiovascular risk, meeting at least one of the following conditions: 1. history of stroke; 2. history of coronary artery disease; 3. history of congestive heart failure; 4. history of peripheral arterial disease; 5. preoperative brain natriuretic peptide (bnp) ≥ 92 mg/l or n-terminal pro-brain natriuretic peptide (nt-probnp) ≥ 300 ng/l; 6. preoperative cardiac troponin (ctn) or high-sensitivity cardiac troponin (hs-ctn) \> upper reference limit; 7. hypertension requiring medication treatment; 8. diabetes requiring medication treatment; 9. history of chronic kidney disease; 10. continuous smoking for 2 years or more, with interruptions of less than one month before the current hospital admission; 11. hypercholesterolemia; 12. history of transient ischemic attack. exclusion criteria: * refuse to participate this trial; * inability to communicate in the preoperative period because of coma, profound dementia, or language barrier; * severe uncontrolled hypertension before surgery (systolic blood pressure ≥ 180 mmhg, diastolic blood pressure ≥ 110 mmhg); * severe hepatic dysfunction (child-pugh class c); or severe renal dysfunction required preoperative dialysis; or american society of anesthesiologists (asa) physical status ≥ v; or expectation lifespan ≤ 24h; * unstable cardiovascular conditions: acute coronary syndrome, decompensated heart failure, severe arrhythmias, severe valvular heart disease; * scheduled to undergo neurosurgical procedures, transplantation, vascular surgery; * urgent surgery; * diagnosed with sepsis or sepsis shock before surgery. * requiring vasopressor treatment before surgery. * unable to finish 24-hour automated blood pressure monitor; * current participation in another interventional study. * any condition deemed ineligible for participation by clinicians.

Keywords: blood pressure postoperative complications mortality non-cardiac surgery