Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05297318
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HPI in Older Patients Undergoing Major Gastrointestinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'patients and care providers did not know the whether the hypotension prediction index use during the operation.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-19', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-weighted average mean arterial pressure less than 65 mmHg', 'timeFrame': 'preoperative and postoperative 30 days', 'description': 'A higher data of time-weighted average mean arterial pressure less than 65 mmHg indicates severe and longer intraoperative hypotension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['the Severity and Duration of Intraoperative Hypotension']}, 'descriptionModule': {'briefSummary': 'The incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)\\<65mmHg). In this study, we aimed to investigate whether HPI could prevent the intraoperative hypotension happened in patients receive elective major gastrointestinal surgery with older than 65 years old.', 'detailedDescription': 'Background: the incidence of intraoperative hypotension was 91%. The increasing incidence of intraoperative hypotension would increase the risk of postoperative complications, such as postoperative arrythmia, stroke or acute kidney injury. Major gastrointestinal surgery is a major surgery. Older patients usually have many comorbidity, such as hypertension or cardiovascular disease. Prevention intraoperative hypotension is an important issue. Hypotension prediction index (HPI) could give the clinician pre-alarm of hypotension (mean arterial pressure (MAP)\\<65mmHg).\n\nObjectives: to investigate whether HPI could prevent the intraoperative hypotension happened.\n\nPatients and methods: The patients receive elective major gastrointestinal surgery with older than 65 years old. These patients have divided into two groups, including with/without HPI guided. The intraoperative hypotension incidence has been measured.\n\nExpected result: The HPI would significantly decrease the intraoperative hypotension incidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the age of patients\\>=65 years old\n* patients receivedd major gastrointestinal surgery\n\nExclusion Criteria:\n\n* patients with major organ dysfunction, such as severe arrythmia, heart failure, under hemodialysis'}, 'identificationModule': {'nctId': 'NCT05297318', 'briefTitle': 'HPI in Older Patients Undergoing Major Gastrointestinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Applying Hypotension Prediction Index Guidance for Prevention of Intraoperative Hypotension in Older Patients Undergoing Major Gastrointestinal Surgery: A Randomized Trial', 'orgStudyIdInfo': {'id': '202112225DIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hypotension prediction index guided', 'description': 'Patients receiving hypotension prediction index guided. In this group, they will be alerted when the index exceeded 85 (range 0 to 100) indicating the later occurrence of MAP\\< 65mmHg for at least minutes and a treatment protocol based on advanced hemodynamic parameters recommended vasopressor or inotrope, fluid administration, or observation.', 'interventionNames': ['Device: hypotension prediction index guided']}, {'type': 'SHAM_COMPARATOR', 'label': 'without hypotesion prediction index guided', 'description': 'Patients will receive usual care during the operation without hypotension prediction index alerted.', 'interventionNames': ['Other: without hypotesion prediction index guided']}], 'interventions': [{'name': 'hypotension prediction index guided', 'type': 'DEVICE', 'description': "patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension", 'armGroupLabels': ['hypotension prediction index guided']}, {'name': 'without hypotesion prediction index guided', 'type': 'OTHER', 'description': 'patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care', 'armGroupLabels': ['without hypotesion prediction index guided']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100225', 'city': 'Taipei', 'state': 'Zhongzheng', 'country': 'Taiwan', 'facility': 'Chih-Jun Lai', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chih-Jun Lai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "ethical issue: patients' privacy"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}