Hypotension Prediction Index (HPI) SMART-BP Trial
Stopped early · Not applicable
Conditions studied: Moderate to High-risk Noncardiac Surgery
In brief
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
Key facts
- Study ID
- NCT05105477
- Run by
- Edwards Lifesciences
- People needed
- 407
- Starts
- 2021-11-17
- Expected to finish
- 2022-12-15
- Last updated by the study team
- 2024-03-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent
- Age >18 years
- ASA Physical Status > 2
- Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
- Planned blood pressure monitoring with an arterial line catheter;
- General anesthesia;
You may not qualify if…
- Participating in another interventional Trial;
- Contraindication to arterial blood pressure monitoring;
- Subjects with a physical site area too limited for proper Sensor placement
- Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
- Scheduled for intracranial surgery with permissive hypotension;
- Patient who is confirmed to be pregnant and/or nursing mothers;
- Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
- Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
- Emergency surgery;
- Require beach-chair positioning;
- Scheduled for cardiac surgeries
- Have previously participated in the SMART-BP trial.
Where it is running
- UC Davis Medical Center — Sacramento, California, United States
- Northwestern University — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Michigan Medical Health System — Ann Arbor, Michigan, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Columbia University — New York, New York, United States
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- UT Southwestern — Dallas, Texas, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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