HPI (Hypotension Prediction Index) Care Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiopulmonary Bypass Surgery

Intervention / Treatment
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* Device: AcumenTM HPI Software Feature
* Other: Non-protocolized Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPI Arm<br>AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB | Device: AcumenTM HPI Software Feature<br>* 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.<br>|
| Placebo Comparator: Non-HPI Arm<br>Non-protocolized standard of care management per clinician and provider judgement. | Other: Non-protocolized Standard of Care<br>* Non-protocolized standard of care to treat subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiopulmonary bypass