Personalized blood pressure management for high-risk patients undergoing major non-cardiac surgery

Effect of Personalized Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Undergoing Major Non-cardiac Surgery: a Randomized Controlled Trial

This trial will test whether tailoring blood pressure targets during major non‑cardiac surgery reduces postoperative heart and kidney injury and death in older, high‑risk adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1624 (estimated)
• Ages: 65 Years to 90 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 7 sites (Guangzhou, Guangdong and 6 other locations)
• Trial ID: NCT06952387 on ClinicalTrials.gov

What this trial studies

This randomized interventional trial will compare personalized intraoperative blood pressure management with routine blood pressure care in older, high‑risk patients undergoing elective major non‑cardiac surgery. Participants aged 65–90 with cardiovascular risk factors and expected surgery duration of at least two hours will be enrolled at hospitals in Guangzhou. The personalized arm sets individualized blood pressure targets to reduce periods of hypotension, while the control arm follows standard intraoperative blood pressure thresholds; investigators will track postoperative myocardial injury, acute kidney injury, and mortality. The design aims to determine whether tailoring blood pressure thresholds can causally reduce ischemic organ injury compared with routine management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65–90 scheduled for elective major non‑cardiac surgery lasting at least two hours who have cardiovascular risk factors such as coronary disease, heart failure, prior stroke, elevated BNP or troponin, treated hypertension or diabetes, chronic kidney disease, or long‑term smoking.

Not a fit: Patients under 65, undergoing minor or emergency surgery, having cardiac surgery, or without cardiovascular risk factors are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, personalized intraoperative blood pressure targets could lower rates of heart and kidney injury and reduce postoperative deaths in high‑risk older adults.

How similar studies have performed: Observational studies strongly link intraoperative hypotension to organ injury, but prior randomized trials of goal‑directed hemodynamic control have produced mixed and inconsistent clinical results.

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.

Where this trial is running

Guangzhou, Guangdong and 6 other locations

• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (ACTIVE_NOT_RECRUITING)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The Affiliated Panyu Central Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)
• The Third People's Hospital of Shenzhen — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (NOT_YET_RECRUITING)
• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Ke-Xuan Liu, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Ke-Xuan Liu, MD

Conditions: Hypotension, Blood Pressure, Postoperative complications, Mortality, Non-cardiac surgery