NCT05083403

HPI (Hypotension Prediction Index) Care Trial

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-28
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2021-10-19
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study