TerminatedNot Applicable

Hypotension Prediction Index (HPI) SMART-BP Trial

Stopped: Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection

United States407 participantsStarted 2021-11-17

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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;

Exclusion criteria

✕. 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;

What they're measuring

A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.

Timeframe: From post non-cardiac surgery to 30 days.

Trial details

NCT IDNCT05105477

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-15

Results submitted2023-12-19

View on ClinicalTrials.gov More Moderate to High-risk Noncardiac Surgery trials