CompletedNCT04972266Updated Dec 4, 2024

The EU Hyprotect Registry

An observational study in Hemodynamic Monitoring, sponsored by Edwards Lifesciences. Completed at 12 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by Edwards Lifesciences · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 702
Ages: 18 Years and older
Sex: All

Study summary

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

Conditions studied

Hemodynamic Monitoring

Browse trials for

Hypotension 1,003

Keywords

Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 702 is above the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Edwards Lifesciences is the lead sponsor of 124 studies on the registry; 19 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 32 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Sampling method: Non-probability sample

Study population

Elective major non-cardiac surgery

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

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 design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 702 participants (actual)
Target follow-up: 30 Days
Patient registry: Yes

Interventions

DeviceAcumenTM Hypotension Prediction Index software
The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.

What researchers measure

Primary outcomes

To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
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

Study locations

12 sites

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04972266
Lead sponsor: Edwards Lifesciences
Collaborators: IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH
Responsible party: Sponsor
First posted: Jul 22, 2021
Start date: Sep 28, 2021
Primary completion: Sep 1, 2022
Completion: Sep 1, 2022
Last update: Dec 4, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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