Cardiopulmonary Bypass SurgeryNCT05083403
HPI (Hypotension Prediction Index) Care Trial
A study testing AcumenTM HPI Software Feature in people with Cardiopulmonary Bypass Surgery, run by Edwards Lifesciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Bypass Surgery
- What is being tested?
- AcumenTM HPI Software Feature
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Subjects with planned cerebral oximetry monitoring
- Subjects with planned overnight hospitalization
- Subjects with planned cardiopulmonary bypass (CPB) "on-pump" surgery
Who cannot join
- 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
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- 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 (defined as pulmonary systolic pressure> 70mmHg or mean pressures > 55mmHg) 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157-1009
About this study
Official title: 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.
- Conditions
- Cardiopulmonary Bypass Surgery
- Being tested
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Keywords
- cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcumenTM HPI Software FeatureDevice
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.
Non-protocolized Standard of CareOther
Non-protocolized standard of care to treat subjects
| Study group | Role | What they receive |
|---|---|---|
| HPI Arm | Experimental | AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB Receives: Device: AcumenTM HPI Software Feature |
| Non-HPI Arm | Placebo comparator | Non-protocolized standard of care management per clinician and provider judgement. Receives: Other: Non-protocolized Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Duration of Hypotension (Defined as MAP < 65mmHg) in Minutes.
Measured: From post-bypass procedure period to the first 8-hour ICU period (one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start28 Mar 2022
- Primary completion14 May 2024
- Study completion29 Sep 2025
Why it stopped: Trial stopped early for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiopulmonary Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083403
- Sponsor's protocol ID
- 2020-19
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2021
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Hypotension Prediction Index in the Cardiac Operating Room and the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05083403
- Acronym / sponsor ID
- 2020-19
- Conditions
- Cardiopulmonary Bypass Surgery
- Keywords
- cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial stopped early for futility
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPI Arm | Experimental | Device: AcumenTM HPI Software FeatureAcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB |
| Non-HPI Arm | Placebo comparator | Other: Non-protocolized Standard of CareNon-protocolized standard of care management per clinician and provider judgement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcumenTM HPI Software FeatureThe 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. | Device | HPI Arm |
| Non-protocolized Standard of CareNon-protocolized standard of care to treat subjects | Other | Non-HPI Arm |
Primary outcome
Mean Duration of Hypotension (Defined as MAP < 65mmHg) in Minutes.
Time frame: From post-bypass procedure period to the first 8-hour ICU period (one day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcumenTM HPI Software Feature in people with Cardiopulmonary Bypass Surgery, run by Edwards Lifesciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Duration of Hypotension (Defined as MAP < 65mmHg) in Minutes. (time frame: From post-bypass procedure period to the first 8-hour ICU period (one day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.