The EU Hyprotect Registry

Hemodynamic Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972266
• Other study ID #: 2021-08
• Status: Completed
• Start date: September 28, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: January 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Monitoring
• Hypotension

Intervention

Device:
• AcumenTM 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Edwards Lifesciences	IPPMed - Institute for Pharmacology and Preventive Medicine

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of the procedure through 30 days after procedure