Status:
RECRUITING
PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Hypotension
Eligibility:
All Genders
65-90 years
Phase:
NA
Brief Summary
High-risk populations, particularly elderly individuals and patients with cardiovascular comorbidities, exhibit markedly elevated incidences of postoperative myocardial injury (MINS), acute kidney inj...
Detailed Description
Anesthesia- and surgery-related complications and mortality constitute a critical global public health burden. Annually, over 300 million surgical procedures are performed worldwide, with postoperativ...
Eligibility Criteria
Inclusion
- 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:
- History of stroke;
- History of coronary artery disease;
- History of congestive heart failure;
- History of peripheral arterial disease;
- Preoperative brain natriuretic peptide (BNP) ≥ 92 mg/L or N-terminal pro-brain natriuretic peptide (NT-proBNP) ≥ 300 ng/L;
- Preoperative cardiac troponin (cTn) or high-sensitivity cardiac troponin (hs-cTn) \> upper reference limit;
- Hypertension requiring medication treatment;
- Diabetes requiring medication treatment;
- History of chronic kidney disease;
- Continuous smoking for 2 years or more, with interruptions of less than one month before the current hospital admission;
- Hypercholesterolemia;
- History of transient ischemic attack.
Exclusion
- 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.
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
1624 Patients enrolled
Trial Details
Trial ID
NCT06952387
Start Date
June 3 2025
End Date
December 1 2028
Last Update
July 14 2025
Active Locations (7)
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1
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
3
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 511431
4
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518112