Hypotension Prediction Index (HPI) SMART-BP Trial

Not Applicable

Terminated

• Conditions: Moderate to High-risk Noncardiac Surgery
• Interventions: Device: AcumenTM HPI Software Feature; Other: Non-protocolized Standard of Care

• Registration Number: NCT05105477
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-03
• Study Start: 2021-11-17
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Results First Submitted: 2023-12-19
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Results First Posted: 2024-03-25
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 407

Inclusion Criteria

1. Signed informed consent
2. Age >18 years
3. ASA Physical Status > 2
4. Noncardiac surgery with expected surgery duration > 2 hours (example include: orthopedic, spine, urology, and general surgery)
5. Planned blood pressure monitoring with an arterial line catheter;
6. General anesthesia;

Exclusion Criteria

1. Participating in another interventional Trial;
2. Contraindication to arterial blood pressure monitoring;
3. Subjects with a physical site area too limited for proper Sensor placement
4. Serum creatine > 175 μmol/L (>2.0 mg/dL) or CKD stage > 3A
5. Scheduled for intracranial surgery with permissive hypotension;
6. Patient who is confirmed to be pregnant and/or nursing mothers;
7. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
8. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
9. Emergency surgery;
10. Require beach-chair positioning;
11. Scheduled for cardiac surgeries
12. Have previously participated in the SMART-BP trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HPI Arm	AcumenTM HPI Software Feature	AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
Non-HPI arm	Non-protocolized Standard of Care	Non-protocolized standard of care management per clinician and provider judgement

Primary Outcome Measures

Name	Time	Method
A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.	From post non-cardiac surgery to 30 days.	A composite of 30-day moderate-to-severe perfusion related postoperative complications.

Trial Locations

Locations (11)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States

UT Southwestern; 🇺🇸 Dallas, Texas, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States

Michigan Medical Health System; 🇺🇸 Ann Arbor, Michigan, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States