NCT05105477

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 25, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

October 22, 2021

Results QC Date

December 19, 2023

Last Update Submit

March 22, 2024

Conditions

Moderate to High-risk Noncardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

HPI Arm

EXPERIMENTAL

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

Device: AcumenTM HPI Software Feature

Non-HPI arm

PLACEBO COMPARATOR

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

Other: Non-protocolized Standard of Care

Interventions

AcumenTM HPI Software FeatureDEVICE

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.

HPI Arm
Non-protocolized Standard of CareOTHER

Non-protocolized standard of care to treat subjects

Non-HPI arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Michigan Medical Health System

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 97239, United States

Location

Oregon Health & Science University

Portland, Oregon, 997239, United States

Location

UT Southwestern

Dallas, Texas, 75235, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Results Point of Contact

Title
Cristina Johnson
Organization
Edwards Lifesciences
CC_Clinical_Affairs@edwards.com
888.713.1564

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 3, 2021

Study Start

November 17, 2021

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

March 25, 2024

Results First Posted

March 25, 2024

Record last verified: 2024-03

Locations

US(11)