Hypotension Prediction Index (HPI) SMART-BP Trial

Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)

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.

Study Overview

• Status: Terminated
• Conditions: Moderate to High-risk Noncardiac Surgery
• Intervention / Treatment: Device: AcumenTM HPI Software Feature; Other: Non-protocolized Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medical Health System
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 97239
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 997239
      • Oregon Health & Science University
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPI Arm; AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.	Device: AcumenTM HPI Software Feature; The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
Placebo Comparator: Non-HPI arm; Non-protocolized standard of care management per clinician and provider judgement	Other: Non-protocolized Standard of Care; Non-protocolized standard of care to treat subjects

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2021-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes