HPI (Hypotension Prediction Index) Care Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiopulmonary Bypass Surgery
• Intervention / Treatment: Device: AcumenTM HPI Software Feature; Other: Non-protocolized Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Johnson; Phone Number: 888.713.1564; Email: Cristine_Johnson@edwards.com

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-1009
      • Recruiting
      • Wake Forest Baptist Medical Center
      • Contact: Ashish K Khanna, MD, FCCP, FCCM, FASA; Email: akhanna@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2020-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes