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Hemodynamic Monitoring

HPI Software for Low Blood Pressure

N/A
Waitlist Available
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from post-bypass period to the first 8-hour icu period

Summary

This trial will test whether a new technology can reduce the duration of low blood pressure in cardiac surgery patients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves software guidance rather than drugs, typical medication side effects aren't expected. However, there may be risks associated with potential changes in patient management based on the software's recommendations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from post-bypass period to the first 8-hour icu period
This trial's timeline: 3 weeks for screening, Varies for treatment, and from post-bypass period to the first 8-hour icu period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment if the use of the AcumenTM HPI Feature Software reduces the mean duration of hypotension (defined as MAP < 65mmHg)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HPI ArmExperimental Treatment1 Intervention
AcumenTM HPI Software Feature to guide hemodynamic management in cardiac surgery post-CPB
Group II: Non-HPI ArmPlacebo Group1 Intervention
Non-protocolized standard of care management per clinician and provider judgement.

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,758 Total Patients Enrolled

Media Library

Acumen HPI Software Feature (Hemodynamic Monitoring) Clinical Trial Eligibility Overview. Trial Name: NCT05083403 — N/A
Cardiopulmonary Bypass Research Study Groups: Non-HPI Arm, HPI Arm
Cardiopulmonary Bypass Clinical Trial 2023: Acumen HPI Software Feature Highlights & Side Effects. Trial Name: NCT05083403 — N/A
Acumen HPI Software Feature (Hemodynamic Monitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05083403 — N/A
~93 spots leftby Jan 2026
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