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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• The Affiliated Panyu Central Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• Guangzhou First People's Hospital
  Guangzhou, Guangdong, China Active not 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

Study contacts

• Principal investigator: Ke-Xuan Liu, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Ke-Xuan Liu, MD
• Email: liukexuan705@163.com
• Phone: 13710684096

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.