Clinical trial NCT04972266: The EU Hyprotect Registry
Official title: European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamic Monitoring
Keywords: Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH
First posted: 2021-07-22
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective major non-cardiac surgery

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


Eligibility criteria: 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

Primary outcomes:
measure: To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
timeFrame: Duration of the procedure through 30 days after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Herne
country: Germany
facility: Marien Hospital Herne, University Hospital Ruhr-University Bochum
state: Rhine-Westphalia
city: Giessen
country: Germany
facility: Justus Liebig University Giessen, University Hospital of Giessen and Marburg
city: Hamburg
country: Germany
facility: University Medical Center Hamburg Eppendorf
city: Marburg
country: Germany
facility: University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General
city: Ancona
country: Italy
facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor, Madrid
city: Clifton
country: United Kingdom
facility: York and Scarborough Teaching Hospitals NHS Foundation Trust
state: York
Study officials:
References: