HPI Software for Low Blood Pressure

Overseen By Cristina Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Heart transplant, Emergency surgery, Severe PAH, others

Compensation: Varies

Number of Visits: Unknown

Duration: From post-bypass period to the first 8-hour ICU period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new software feature, Acumen HPI, to determine its effectiveness in managing low blood pressure during and after heart surgery. The goal is to see if this software can reduce the duration of low blood pressure, a common concern during cardiac procedures. Participants are divided into two groups: one receiving standard care and the other using the Acumen HPI software. Suitable candidates for this trial are those scheduled for heart surgery involving a heart-lung machine. As an unphased trial, this study allows patients to contribute to innovative research that could enhance heart surgery outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Acumen HPI Software Feature is safe for cardiac surgery patients?

Research has shown that the Acumen HPI (Hypotension Prediction Index) software is generally safe for patients. In studies, this software helped prevent low blood pressure in 41% of patients, compared to only 12% in studies without it. It also reduces the duration of low blood pressure during surgery by 35%. Importantly, no major safety issues or negative effects have been directly linked to the software. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Acumen HPI Software Feature because it offers a novel way to manage low blood pressure during cardiac surgery. Unlike traditional methods that rely on clinician judgment and standard protocols, this software uses advanced algorithms to provide real-time guidance for hemodynamic management. This innovative approach could lead to more precise and personalized treatment, potentially improving patient outcomes by maintaining optimal blood pressure levels during critical surgical procedures.

What evidence suggests that the Acumen HPI Software is effective for reducing low blood pressure in cardiac surgery patients?

Research has shown that the Acumen HPI Software effectively manages low blood pressure during surgery. In this trial, participants in the HPI Arm will be monitored with this software. Specifically, the software demonstrated that 41% of patients avoided low blood pressure, compared to only 12% in another group. It uses a special program to predict and help prevent drops in blood pressure by analyzing detailed data. This assists doctors in maintaining stable blood pressure during surgery, reducing complications. Overall, the software appears promising in improving patient outcomes by preventing dangerous drops in blood pressure. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who are scheduled for 'on-pump' heart surgery with an overnight hospital stay. They must be in a stable physical condition (ASA ≤ 4), have no severe low heart function or pulmonary hypertension, and not be part of another study. Emergency surgery patients or those needing a heart transplant are excluded.

Inclusion Criteria

Subjects who have signed the Informed Consent Form

Subjects with planned pressure monitoring with an arterial line

I am scheduled for a chest surgery that involves opening the breastbone.

Exclusion Criteria

My heart's lung pressure is very high, confirmed by tests.

I needed to go back on heart-lung machine support during surgery due to unstable heart conditions.

Subjects with contraindications for Arterial Line Placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Guided hemodynamic management with Acumen HPI technology in the OR and ICU

From post-bypass period to the first 8-hour ICU period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acumen HPI Software Feature

Trial Overview The trial tests if the Acumen HPI software can reduce how long patients experience low blood pressure after cardiac surgery with cardiopulmonary bypass. Patients will either use this technology-guided care or receive standard care without protocol guidance.

How Is the Trial Designed?

Group I: HPI Arm Experimental Treatment 1 Intervention

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

Group II: Non-HPI Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

The Mobile You Blood Pressure Program, an interactive voice response (IVR) system linked to electronic health records, was implemented to improve blood pressure monitoring among hypertensive patients, enrolling 71 patients across 14 clinics.

The program faced challenges, particularly with patient enrollment, as access to validated home blood pressure monitors was identified as a significant barrier by pharmacists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and barriers to uptake of interactive voice response technology aimed to improve blood pressure control at a large academic medical center. Ashjian, EJ., Yoo, A., Piette, JD., et al.[2020]

The ARTEMIS system, implemented since 1975, effectively manages hypertensive patients by integrating individual patient records, facilitating follow-up, and aiding decision-making, with over 22,000 records registered across five clinics in France.

A prospective evaluation of the expert system showed a high agreement rate (58% to 91%) with specialists on hypertension cases, indicating its potential reliability in diagnosing and managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted techniques for evaluation and treatment of hypertensive patients. Degoulet, P., Chatellier, G., Devriès, C., et al.[2019]

Citations

1. edwards.com edwards.com/healthcare-professionals/products-services/predictive-monitoring/hpi

Acumen Hypotension Prediction Index software 41% of patients avoided hypotension when monitored with Acumen HPI software, compared to 12% of patients in another large multicenter study where Acumen HPI ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9571548/

Hypotension Prediction Index Software to Prevent ... The HPI algorithm was modeled and cross-validated in 1334 surgical and critically ill patients using 545,959 min of arterial blood pressure waveform recordings ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-03086-y

Hypotension prediction index: comparison between invasive ... The Hypotension Prediction Index (HPI) derived using an Acumen™ arterial pressure transducer can decrease the incidence of intraoperative ...

4. edwards.com edwards.com/healthcare-professionals/products-services/predictive-monitoring/hpi-clinical-evidence

Acumen Hypotension Prediction Index (HPI) Software 41% of patients avoided hypotension when monitored with Acumen HPI software, compared to 12% of patients in another large multicenter study where Acumen HPI ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT03610165/Prot_SAP_000.pdf

The Role of Acumen Hypotension Prediction Index ... addition of Acumen HPI software guidance to the invasive arterial pressure monitoring on intraoperative hypotension duration and severity.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN160044.pdf

DEN160044.pdf - accessdata.fda.gov The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into a patient's likelihood of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10913612/

AcumenTM hypotension prediction index guidance for ... We report that the use of the hypotension prediction algorithm was associated with a 35% reduction in the duration of intraoperative hypotension ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03805217

Hypotension Prediction Index Study (HPI Study) It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...