HPI (Hypotension Prediction Index) Care Trial

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05083403

Collaborator

(none)

350

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective single-center randomized controlled trial to determine if guided hemodynamic management with the Acumen HPI technology in the OR and ICU can reduce the mean duration of hypotension in cardiac surgery patients requiring cardiopulmonary bypass.

Condition or Disease	Intervention/Treatment	Phase
Cardiopulmonary Bypass Surgery	Device: AcumenTM HPI Software Feature Other: Non-protocolized Standard of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Randomized Trial of the Hypotension Prediction Index in the Cardiac Operating Room and the Intensive Care Unit

Actual Study Start Date :

Mar 28, 2022

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Sep 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HPI Arm AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB	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

Arm

Intervention/Treatment

Experimental: HPI Arm

AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB

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

Outcome Measures

Primary Outcome Measures

Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg) [From post-bypass period to the first 8-hour ICU period]
Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects who are at least 18 years of age
Subjects who have signed the Informed Consent Form
Subjects with planned pressure monitoring with an arterial line
Subjects with planned sternotomy
Subjects with planned general anesthesia
Subjects who have ASA Physical Status ≤ 4
Subjects with planned cerebral oximetry monitoring
Subjects with planned overnight hospitalization
Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery

Exclusion Criteria:

Subjects with a physical site area too limited for proper Sensor placement
Subjects with contraindications for Arterial Line Placement;
Subjects participating in another (interventional) study
Subjects in whom an intraoperative MAP target will be < 65 mmHg
Subjects with pre-op or pre-pump or post-pump LVEF ≤ 15%
Subjects requiring heart transplant
Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass
Subjects requiring emergency surgery
Subjects with known or identified severe PAH as determined by a pre-operative echo or intraoperative Swan-Ganz
Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	United States	27157-1009

Sponsors and Collaborators

Edwards Lifesciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Edwards Lifesciences

ClinicalTrials.gov Identifier:

NCT05083403

Other Study ID Numbers:

2020-19

First Posted:

Oct 19, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Edwards Lifesciences

cardiopulmonary bypass

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Mar 31, 2022