Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-30 @ 7:06 AM
Study NCT ID:
NCT04872504
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2021-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypotension Prediction Index in Patients Undergoing Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-05-03', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accurate hypotension prediction of EV1000 system', 'timeFrame': 'MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.', 'description': 'Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min'}, {'measure': 'Incidence of intraoperative hypotension', 'timeFrame': 'MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day', 'description': 'Frequency, duration of intraoperative hypotension, which defined as MAP \\< 65 mmHg at least 1 min'}, {'measure': 'Severity of intraoperative hypotension', 'timeFrame': 'MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day', 'description': 'MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) \\< 65 mmHg'}], 'secondaryOutcomes': [{'measure': 'Hospital stay and ICU stay', 'timeFrame': 'Days from admission to discharge, assessed up to 1 month', 'description': "The incidence and severity of intraoperative hypotension correlate with patient's hospital stay and ICU stay"}, {'measure': 'Mortality after surgery', 'timeFrame': 'Days from admission to discharge, assessed up to 1 month', 'description': "The incidence and severity of intraoperative hypotension correlate with patient's mortality"}, {'measure': 'Adverse effects', 'timeFrame': 'Days from admission to discharge, assessed up to 1 month', 'description': 'The incidence and severity of hypotension correlate with the adverse effects like acute liver failure, acute kidney injury and acute myocardial injury'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Intraoperative Hypotension']}, 'descriptionModule': {'briefSummary': 'A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age ≥ 20 years;\n* Scheduled liver transplantation\n* Planned pressure monitoring with an arterial line;\n* General anesthesia\n\nExclusion Criteria:\n\n* Contraindication for invasive blood pressure monitoring\n* End-staged renal disease\n* pre-operative MAP \\<65 mmHg\n* Severe heart failure\n* Severe cardiac shunt\n* Severe aortic stenosis\n* Severe atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT04872504', 'briefTitle': 'Hypotension Prediction Index in Patients Undergoing Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation', 'orgStudyIdInfo': {'id': 'Hypotension prediction index'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acumen HPI-enabled EV1000 screen', 'description': 'Acumen HPI-enabled EV1000 screen', 'interventionNames': ['Device: Acumen HPI-enabled EV1000 screen']}], 'interventions': [{'name': 'Acumen HPI-enabled EV1000 screen', 'type': 'DEVICE', 'description': 'Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension', 'armGroupLabels': ['Acumen HPI-enabled EV1000 screen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yung Fong Tsai, PHD', 'role': 'CONTACT'}], 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'BO HAN YEH', 'role': 'CONTACT', 'email': '100311047@gms.tcu.edu.tw', 'phone': '+886978989006'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}