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HPI (Hypotension Prediction Index) Care Trial

NCT05083403 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-06-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2025-10-31
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083403 on ClinicalTrials.gov