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

350 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Acumen HPI Software Feature for low blood pressure?

The research highlights the potential of health information technology, like the Acumen HPI Software, to improve blood pressure management by providing clinical decision support and data visualization. Although the studies focus on hypertension (high blood pressure), the principles of using technology to monitor and manage blood pressure could be relevant for low blood pressure as well. ^{1 2 3 4 5}

How does the Acumen HPI Software Feature treatment for low blood pressure differ from other treatments?

The Acumen HPI Software Feature is unique because it uses advanced software to assist in decision-making for managing low blood pressure, unlike traditional treatments that rely solely on medication. This software provides a personalized approach by analyzing patient data to optimize treatment strategies. ^{5 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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 pre-existing circulatory support devices or planned circulatory support devices post-bypass

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Patient support ICT tool for hypertension monitoring. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Using health information technology to improve hypertension management. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Benefit of home blood pressure measurement after a finding of high blood pressure at a community screening. [2006]

4. United States 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. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

BP: a microcomputer program for use in a hypertension clinic. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Computer supported decision making in therapy of arterial hypertension. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[A computerized medical record for the follow-up of hypertensive patients (author's transl)]. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

Computer-assisted techniques for evaluation and treatment of hypertensive patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Computer-aided management of hypertensive patients. [2019]