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ACTIVE NOT RECRUITING NA

HPI (Hypotension Prediction Index) Care Trial

NCT05083403 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE AcumenTM HPI Software Feature
  • OTHER Non-protocolized Standard of Care

Study Locations (1)

North Carolina

  • Wake Forest Baptist Medical Center — Winston-Salem

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2022-03-28
Est. Completion 2025-11
Phase NA

Sponsor

Edwards Lifesciences

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05083403

The ClinicalTrials.gov registry entry for NCT05083403 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cardiopulmonary Bypass Surgery appearing as the primary indexed condition, and to 2 interventions — of which AcumenTM HPI Software Feature is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05083403 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05083403 about?

NCT05083403 is a clinical study titled "HPI (Hypotension Prediction Index) Care 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.

What is the current status of trial NCT05083403?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2022-03-28. Estimated completion is 2025-11.

What conditions does trial NCT05083403 study?

This clinical trial studies the following conditions: Cardiopulmonary Bypass Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05083403?

The interventions under investigation include: AcumenTM HPI Software Feature (DEVICE), Non-protocolized Standard of Care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05083403?

This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05083403 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial