HPI (Hypotension Prediction Index) Care Trial

NCT ID: NCT05083403

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

HPI Arm

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

Group Type: EXPERIMENTAL

AcumenTM HPI Software Feature

Intervention Type: 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.

Non-HPI Arm

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

Group Type: PLACEBO_COMPARATOR

Non-protocolized Standard of Care

Intervention Type: OTHER

Non-protocolized standard of care to treat subjects

Interventions

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.

Intervention Type: DEVICE

Non-protocolized Standard of Care

Non-protocolized standard of care to treat subjects

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Subjects who are at least 18 years of age

2. Subjects who have signed the Informed Consent Form

3. Subjects with planned pressure monitoring with an arterial line

4. Subjects with planned sternotomy

5. Subjects with planned general anesthesia

6. Subjects who have ASA Physical Status ≤ 4

7. Subjects with planned cerebral oximetry monitoring

8. Subjects with planned overnight hospitalization

9. Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery

Exclusion Criteria

1. Subjects with a physical site area too limited for proper Sensor placement

2. Subjects with contraindications for Arterial Line Placement;

3. Subjects participating in another (interventional) study

4. Subjects in whom an intraoperative MAP target will be < 65 mmHg

5. Subjects with pre-op or pre-pump or post-pump LVEF < 15%

6. Subjects requiring heart transplant

7. Subjects with pre-existing circulatory support devices or planned circulatory support devices post-bypass

8. Subjects requiring emergency surgery

9. 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

10. Subjects with cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

2020-19

Identifier Type: -

Identifier Source: org_study_id