Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 11:19 AM
Study NCT ID:
NCT06799832
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-23', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average intraoperative urethral perfusion index', 'timeFrame': 'Start of surgery until end of surgery'}], 'secondaryOutcomes': [{'measure': 'the absolute lowest intraoperative urethral perfusion index', 'timeFrame': 'Start of surgery until end of surgery'}, {'measure': 'the lowest intraoperative 5-minute moving average urethral perfusion index', 'timeFrame': 'Start of surgery until end of surgery'}, {'measure': 'the intraoperative area under the baseline urethral perfusion index', 'timeFrame': 'Start of surgery until end of surgery'}, {'measure': 'the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index', 'timeFrame': 'Start of surgery until end of surgery'}, {'measure': 'the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index', 'timeFrame': 'Start of surgery until end of surgery'}, {'measure': 'intraoperative area under a urethral perfusion index value 30% below baseline', 'timeFrame': 'Start of surgery until end of surgery'}, {'measure': 'cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline', 'timeFrame': 'Start of surgery until end of surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['urethral perfusion index', 'tissue perfusion', 'microcirculation'], 'conditions': ['Urethral Perfusion Index', 'Tissue Perfusion', 'Microcirculation']}, 'descriptionModule': {'briefSummary': 'We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 45 years old\n* scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes)\n* indication for an arterial catheter\n* indication for an urinary catheter\n\nExclusion Criteria:\n\n* Pregnancy\n* Planned surgery: nephrectomy, liver or kidney transplantation surgery\n* Patients who previously had surgery on the urethra or bladder\n* Patients without clinical indication for continuous blood pressure monitoring with an intraarterial catheter'}, 'identificationModule': {'nctId': 'NCT06799832', 'acronym': 'UPRIGHT', 'briefTitle': 'Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial', 'orgStudyIdInfo': {'id': '2024-101408-BO-ff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine hemodynamic management', 'description': 'In patients assigned to routine hemodynamic management, hemodynamic management will be performed according to routine care. The urethral perfusion index measurements will not be visible.'}, {'type': 'EXPERIMENTAL', 'label': 'Urethral perfusion index guided hemodynamic monitoring', 'description': "In patients assigned to urethral perfusion index-guided hemodynamic monitoring, clinicians will be asked to maintaining the intraoperative urethral perfusion index above the postinduction baseline urethral perfusion index during surgery. Interventions to maintain intraoperative urethral perfusion index will be at the clinicians' discretion. All other medical procedures will be performed according to routine care. Clinical judgement will always prevail. Additionally, we will always strive to maintain macrocirculatory variables within predefined safety ranges: Mean arterial pressure: 60 mmHg - 120 mmHg Heart rate: 30 bpm - 120 bpm Cardiac index: at least 2.2 L/min/m2", 'interventionNames': ['Device: urethal perfusion index monitoring']}], 'interventions': [{'name': 'urethal perfusion index monitoring', 'type': 'DEVICE', 'description': 'The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)', 'armGroupLabels': ['Urethral perfusion index guided hemodynamic monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Bernd Saugel, MD', 'role': 'CONTACT', 'email': 'b.saugel@uke.de', 'phone': '+49 (0) 40 7410 - 52415'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Bernd Saugel, MD', 'role': 'CONTACT', 'email': 'b.saugel@uke.de', 'phone': '+49741052415'}, {'name': 'Moritz Flick, MD', 'role': 'CONTACT', 'email': 'm.flick@uke.de', 'phone': '+49741052415'}], 'overallOfficials': [{'name': 'Bernd Saugel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}