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Hypotension Prediction Index (HPI) SMART-BP Trial

Primary Purpose

Moderate to High-risk Noncardiac Surgery

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AcumenTM HPI Software Feature
Non-protocolized Standard of Care
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Moderate to High-risk Noncardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UC Davis Medical Center
  • Northwestern University
  • Massachusetts General Hospital
  • Michigan Medical Health System
  • Henry Ford Health System
  • Columbia University
  • Wake Forest Baptist Medical Center
  • Cleveland Clinic
  • Oregon Health & Science University
  • UT Southwestern
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPI Arm

Non-HPI arm

Arm Description

AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Non-protocolized standard of care management per clinician and provider judgement

Outcomes

Primary Outcome Measures

A composite of 30-day moderate-to-severe perfusion related postoperative complications.
A composite of 30-day moderate-to-severe perfusion related postoperative complications.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2021
Last Updated
January 31, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT05105477
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Halted prematurely; voluntarily discontinuation of trial as study specific protocol not followed during data collection
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to High-risk Noncardiac Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HPI Arm
Arm Type
Experimental
Arm Description
AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.
Arm Title
Non-HPI arm
Arm Type
Placebo Comparator
Arm Description
Non-protocolized standard of care management per clinician and provider judgement
Intervention Type
Device
Intervention Name(s)
AcumenTM HPI Software Feature
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-protocolized Standard of Care
Intervention Description
Non-protocolized standard of care to treat subjects
Primary Outcome Measure Information:
Title
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Description
A composite of 30-day moderate-to-severe perfusion related postoperative complications.
Time Frame
From post non-cardiac surgery to 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; Emergency surgery; Require beach-chair positioning; Scheduled for cardiac surgeries Have previously participated in the SMART-BP trial.
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan Medical Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
997239
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hypotension Prediction Index (HPI) SMART-BP Trial

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