HPI (Hypotension Prediction Index) Care Trial

Cardiopulmonary Bypass Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05083403
• Other study ID #: 2020-19
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Edwards Lifesciences
• Contact: Cristina Johnson
• Phone: 888.713.1564
• Email: Cristine_Johnson[@]edwards.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass Surgery
• Hypotension

Intervention

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.

Other:
• Non-protocolized Standard of Care
Non-protocolized standard of care to treat subjects

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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