Hemodynamic MonitoringNCT04972266
The EU Hyprotect Registry
An observational study of Hemodynamic Monitoring, run by Edwards Lifesciences at 12 sites in 5 countries.
Trial summary
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Monitoring
- What is being tested?
- AcumenTM Hypotension Prediction Index software
- Type of treatment
- Medical device
- How many people
- 702 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 28 Sep 2021to 1 Sep 2022
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Elective major non-cardiac surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany4 sites
Justus Liebig University Giessen, University Hospital of Giessen and Marburg
Giessen, 35392
University Medical Center Hamburg Eppendorf
Hamburg, 202246
Marien Hospital Herne, University Hospital Ruhr-University Bochum
Herne, Rhine-Westphalia, 44625
University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg
Marburg, 35037
Italy3 sites
Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General
Ancona, 60126
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona
Ancona, 60126
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
France2 sites
Hôpital Lariboisière
Paris, 75010
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Spain2 sites
Hospital Universitario Infanta Leonor, Madrid
Madrid, 28031
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
United Kingdom1 site
York and Scarborough Teaching Hospitals NHS Foundation Trust
Clifton, York, YO31 8HE
About this study
Official title: 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
- Conditions
- Hemodynamic Monitoring
- Being tested
- AcumenTM Hypotension Prediction Index software
- Keywords
- Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcumenTM Hypotension Prediction Index softwareDevice
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 is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Duration of the procedure through 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start28 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 702 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972266
- Sponsor's protocol ID
- 2021-08
- Status last verified
- Jan 2023
- First submitted
- 15 Jul 2021
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry
- ClinicalTrials.gov ID
- NCT04972266
- Acronym / sponsor ID
- 2021-08
- Conditions
- Hemodynamic Monitoring
- Keywords
- Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elective major non-cardiac surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcumenTM Hypotension Prediction Index softwareThe 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. | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Hemodynamic Monitoring
Recruiting
The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery
Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours
Recruiting
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
Surgery Complications
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia
Not yet recruitingObservational study
Integrated Near-Infrared Spectroscopy and Hemodynamic Monitoring for Cerebral Autoregulation in Post-Cardiac Arrest Care Neuroprognostication
Cardiac Arrest (CA)
Not yet recruitingObservational study
Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
Septic Shock, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Monitoring, run by Edwards Lifesciences at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Italy, France, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.