PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery

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.

Eligibility

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.

Conditions2

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