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Hypotension Prediction Index (HPI) SMART-BP Trial

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ClinicalTrials.gov Identifier: NCT05105477
Recruitment Status : Terminated (Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection)
First Posted : November 3, 2021
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Moderate to High-risk Noncardiac Surgery Device: AcumenTM HPI Software Feature Other: Non-protocolized Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Hypotension Prediction Index (HPI) Software Guided Hemodynamic Management for Noncardiac Surgery Patients - Blood Pressure Trial (National PI: Kamal Maheshwari, MD, MPH)
Actual Study Start Date : November 17, 2021
Actual Primary Completion Date : December 15, 2022
Actual Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. A composite of 30-day moderate-to-severe perfusion related postoperative complications. [ Time Frame: From post non-cardiac surgery to 30 days. ]
    A composite of 30-day moderate-to-severe perfusion related postoperative complications.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05105477


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Michigan Medical Health System
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 97239
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 997239
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75235
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Edwards Lifesciences
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT05105477    
Other Study ID Numbers: 2021-04
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023

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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
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases