NCT06952387 PeRsonalized Blood prEssure Management on Postoperative Complications and Mortality in hIgh-risk Patients Undergoing Major Non-cardiac Surgery
| NCT ID | NCT06952387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,624 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,624 participants in total. It began in 2025-06-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Ke-Xuan Liu, MD
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06952387 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 Years, studying Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06952387 currently recruiting?
Yes, NCT06952387 is actively recruiting participants. Contact the research team at liukexuan705@163.com for enrollment information.
Where is the NCT06952387 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Shenzhen, China and 3 additional locations.
Who is sponsoring the NCT06952387 clinical trial?
NCT06952387 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Ke-Xuan Liu, MD at Nanfang Hospital, Southern Medical University. The trial plans to enroll 1,624 participants.