Clinical trial NCT05105477: Hypotension Prediction Index (HPI) SMART-BP Trial
Official title: Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Moderate to High-risk Noncardiac Surgery
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2021-11-03
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.
timeFrame: From post non-cardiac surgery to 30 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medical Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: