Comparing blood pressure management strategies during major surgery
Effect of Individualized Versus Conventional Blood Pressure Management on Major Adverse Cardiac, Cerebrovascular, and Renal Events After Major Non-cardiac Surgery: Multicenter, Randomized Controlled Trial
This study is testing whether a personalized blood pressure management plan during major surgery can lead to better recovery outcomes compared to a standard approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1896 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 5 sites (Seongnam and 4 other locations) |
| Trial ID | NCT06225453 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effects of individualized versus conventional blood pressure management strategies on postoperative outcomes in patients undergoing major non-cardiac surgery. Participants will be randomly assigned to either an individualized strategy, which maintains blood pressure within 20% of their baseline values, or a conventional strategy, which targets a minimum mean arterial pressure of 65 mmHg and systolic blood pressure of 90 mmHg. The study will assess the frequency of major adverse outcomes within 7 days post-surgery or before discharge. The trial reflects real clinical scenarios by allowing flexibility in perioperative management while focusing on blood pressure targets.
Who should consider this trial
Good fit: Ideal candidates include patients aged 65 and older or those aged 45 and older with a history of cardiovascular issues, undergoing non-cardiac surgery lasting at least 2 hours.
Not a fit: Patients undergoing emergency surgeries, organ transplants, or those with severe pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complications for patients undergoing major non-cardiac surgeries.
How similar studies have performed: Other studies have explored blood pressure management in surgical settings, but this specific individualized approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥65 or, * those aged ≥45 with a history of coronary artery disease, peripheral vascular disease, transient ischemic attack/stroke, or congestive heart failure, * undergoing non-cardiac surgery under general anesthesia with an anticipated duration of ≥2 hours. Exclusion Criteria: * Emergency surgery * Organ transplantation surgery * Brain/carotid artery surgery * American Society of Anesthesiologists physical status 5 or 6 * Pregnancy * Uncontrolled preoperative hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) * Estimated glomerular filtration rate \<30 ml/min/1.73m2 * Renal replacement therapy * Acute decompensated heart failure * Sepsis * Shock * Use of inotropes/vasopressor infusion (dopamine, norepinephrine, vasopressin, etc.)
Where this trial is running
Seongnam and 4 other locations
- Seoul National University Bundang Hospital — Seongnam, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Ajou University Hospital — Suwon, South Korea (Recruiting)
Study contacts
- Principal investigator: Karam nam, M.D., Ph.D. — Seoul National University Hospital
- Study coordinator: Karam Nam, M.D., Ph.D.
- Email: karamnam@gmail.com
- Phone: 82-2-2072-0643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.