HPI (Hypotension Prediction Index) Care Trial
Stopped early · Not applicable
Conditions studied: Cardiopulmonary Bypass Surgery
In brief
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.
Key facts
- Study ID
- NCT05083403
- Run by
- Edwards Lifesciences
- People needed
- 170
- Starts
- 2022-03-28
- Expected to finish
- 2025-09-29
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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