HPI (Hypotension Prediction Index) Care Trial

NCT05083403 | Active Not Recruiting FDA Device

• 1 other identifier: 2020-19
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiopulmonary Bypass Surgery

Keywords

cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)

  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

Study Arms (2)

HPI Arm

EXPERIMENTAL

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

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 Feature DEVICE

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 Care OTHER

Non-protocolized standard of care to treat subjects

Non-HPI Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 (defined as pulmonary systolic pressure\> 70mmHg or mean pressures \> 55mmHg) 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157-1009, United States

Location

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 6, 2021
• First Posted: October 19, 2021
• Study Start: March 28, 2022
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)