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

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Apr 23, 2025

Keywords

ClinConnect Summary

The PREMIUM trial is a clinical study aimed at understanding how personalized blood pressure management during major non-cardiac surgeries can reduce complications and improve outcomes for high-risk patients. This trial focuses on older adults, particularly those aged 65 to 90, who are scheduled for elective surgeries that last at least two hours and require a hospital stay of two days or more afterward. Eligible participants are those with existing heart conditions or other significant health issues, such as a history of stroke, heart disease, or chronic kidney problems.

If you or a loved one qualifies for this trial, you can expect to receive tailored blood pressure management during surgery to see if it helps reduce the risk of serious complications like heart injury or kidney problems. The study is not yet recruiting participants, but it aims to clarify the best ways to manage blood pressure for those at high risk during surgery, potentially improving recovery and reducing complications.

Gender

ALL

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.