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

Recruiting now · Not applicable

Conditions studied: Hypotension

In brief

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.

Key facts

Study ID

NCT06952387

Run by

Nanfang Hospital, Southern Medical University

People needed

1624

Starts

2025-06-03

Expected to finish

2028-12-01

Last updated by the study team

2025-07-14

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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