HPI (Hypotension Prediction Index) Care Trial

Not Applicable

Active, not recruiting

• Conditions: Cardiopulmonary Bypass Surgery
• Interventions: Device: AcumenTM HPI Software Feature; Other: Non-protocolized Standard of Care

• Registration Number: NCT05083403
• Lead Sponsor: Edwards Lifesciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2022-03-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HPI Arm	AcumenTM HPI Software Feature	AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
Non-HPI Arm	Non-protocolized Standard of Care	Non-protocolized standard of care management per clinician and provider judgement.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States