Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-27 @ 2:11 AM
Study NCT ID:
NCT04972266
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2021-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The EU Hyprotect Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 702}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'To describe the time-weighted average (TWA) mean arterial pressure (MAP) \\<65 mmHg when using AcumenTM Hypotension Prediction Index software'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Intraoperative hypotension, Preventive Therapy, Blood pressure monitoring'], 'conditions': ['Hemodynamic Monitoring']}, 'descriptionModule': {'briefSummary': 'European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elective major non-cardiac surgery', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting adult patients (≥18 years)\n* 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\n* Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation\n* Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition)\n* American Society of Anesthesiology (ASA) physical status classification V or VI\n* Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation\n* Pregnancy at the time of surgery\n* Patients without signed informed consent / data protection statement\n* Patient participating in other interventional trials'}, 'identificationModule': {'nctId': 'NCT04972266', 'briefTitle': 'The EU Hyprotect Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry', 'orgStudyIdInfo': {'id': '2021-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AcumenTM Hypotension Prediction Index software', 'type': 'DEVICE', 'description': "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."}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Les Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '44625', 'city': 'Herne', 'state': 'Rhine-Westphalia', 'country': 'Germany', 'facility': 'Marien Hospital Herne, University Hospital Ruhr-University Bochum', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Justus Liebig University Giessen, University Hospital of Giessen and Marburg', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '202246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '35037', 'city': 'Marburg', 'country': 'Germany', 'facility': 'University Hospital Philipps-Universität Marburg, University Hospital of Giessen and Marburg', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Ospedali Riuniti "Umberto I° General', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '60126', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor, Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'YO31 8HE', 'city': 'Clifton', 'state': 'York', 'country': 'United Kingdom', 'facility': 'York and Scarborough Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.63331, 'lon': -2.72324}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'IPPMed - Institut für Pharmakologie und Präventive Medizin GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}