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HPI (Hypotension Prediction Index) Care Trial

Primary Purpose

Cardiopulmonary Bypass Surgery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AcumenTM HPI Software Feature
Non-protocolized Standard of Care
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiopulmonary Bypass Surgery focused on measuring cardiopulmonary bypass

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Wake Forest Baptist Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HPI Arm

Non-HPI Arm

Arm Description

AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB

Non-protocolized standard of care management per clinician and provider judgement.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 6, 2021
Last Updated
March 28, 2022
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT05083403
Brief Title
HPI (Hypotension Prediction Index) Care Trial
Official Title
A Randomized Trial of the Hypotension Prediction Index in the Cardiac Operating Room and the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Bypass Surgery
Keywords
cardiopulmonary bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPI Arm
Arm Type
Experimental
Arm Description
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
Arm Title
Non-HPI Arm
Arm Type
Placebo Comparator
Arm Description
Non-protocolized standard of care management per clinician and provider judgement.
Intervention Type
Device
Intervention Name(s)
AcumenTM HPI Software Feature
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-protocolized Standard of Care
Intervention Description
Non-protocolized standard of care to treat subjects
Primary Outcome Measure Information:
Title
Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)
Description
Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)
Time Frame
From post-bypass period to the first 8-hour ICU period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Akagha
Phone
(949)250-7169
Email
Kathy_Akagha@edwards.com
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish K Khanna, MD, FCCP, FCCM, FASA
Email
akhanna@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HPI (Hypotension Prediction Index) Care Trial

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