HPI (Hypotension Prediction Index) Care Trial

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Cardiopulmonary Bypass Surgery

Treatments: Device: AcumenTM HPI Software Feature; Other: Non-protocolized Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05083403

2020-19

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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350 participants in 2 patient groups, including a placebo group

HPI Arm

Experimental group

Description:

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

Treatment:

Device: AcumenTM HPI Software Feature

Non-HPI Arm

Placebo Comparator group

Description:

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

Treatment:

Other: Non-protocolized Standard of Care