The EU Hyprotect Registry

December 2, 2024 updated by: Edwards Lifesciences

European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry

European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

702

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Strasbourg, France, 67091
        • Les Hôpitaux Universitaires de Strasbourg
  • Germany
      • Giessen, Germany, 35392
        • Justus Liebig University Giessen, University Hospital of Giessen and Marburg
      • Hamburg, Germany, 202246
        • University Medical Center Hamburg Eppendorf
      • Marburg, Germany, 35037
        • University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg
    • Rhine-Westphalia
      • Herne, Rhine-Westphalia, Germany, 44625
        • Marien Hospital Herne, University Hospital Ruhr-University Bochum
  • Italy
      • Ancona, Italy, 60126
        • Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General
      • Ancona, Italy, 60126
        • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Spain
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor, Madrid
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
  • United Kingdom
    • York
      • Clifton, York, United Kingdom, YO31 8HE
        • York and Scarborough Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Elective major non-cardiac surgery

Description

Inclusion Criteria:

  • Consenting adult patients (≥18 years)
  • Patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter
  • Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively

Exclusion Criteria:

  • Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation
  • Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition)
  • American Society of Anesthesiology (ASA) physical status classification V or VI
  • Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation
  • Pregnancy at the time of surgery
  • Patients without signed informed consent / data protection statement
  • Patient participating in other interventional trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
Time Frame: Duration of the procedure through 30 days after procedure
To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
Duration of the procedure through 30 days after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Collaborators

IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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