Actively Recruiting
PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery
Led by Nanfang Hospital, Southern Medical University · Updated on 2025-07-14
1624
Participants Needed
7
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 65 to 90 years
- Scheduled for elective major non-cardiac surgery under general anesthesia lasting 2 hours or more
- Expected postoperative hospital stay of 2 days or more
- High cardiovascular risk with at least one of the following: history of stroke, coronary artery disease, congestive heart failure, 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) above the upper reference limit
- Hypertension requiring medication
- Diabetes requiring medication
- History of chronic kidney disease
- Continuous smoking for 2 years or more, with interruptions less than one month before admission
- Hypercholesterolemia
- History of transient ischemic attack
You will not qualify if you...
- Refusal to participate
- Unable to communicate preoperatively due to coma, profound dementia, or language barrier
- Severe uncontrolled hypertension before surgery (systolic BP ≥ 180 mmHg, diastolic BP ≥ 110 mmHg)
- Severe liver dysfunction (Child-Pugh Class C)
- Severe kidney dysfunction requiring preoperative dialysis
- ASA physical status ≥ V
- Expected lifespan ≤ 24 hours
- Unstable cardiovascular conditions including acute coronary syndrome, decompensated heart failure, severe arrhythmias, severe valvular heart disease
- Scheduled for neurosurgery, transplantation, or vascular surgery
- Urgent surgery
- Diagnosed with sepsis or septic shock before surgery
- Requiring vasopressor treatment before surgery
- Unable to complete 24-hour automated blood pressure monitoring
- Currently participating in another interventional study
- Any condition deemed ineligible by clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Active, Not Recruiting
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
3
The Affiliated Panyu Central Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 511431
Actively Recruiting
4
The Third People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518112
Not Yet Recruiting
5
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Not Yet Recruiting
6
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
7
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
Research Team
K
Ke-Xuan Liu, MD
CONTACT
S
Shuang-Jie Cao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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