Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-01-04 @ 7:20 PM
Study NCT ID:
NCT05183061
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2021-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Post-induction Hypotension in iNPH Patient Undergoing VP and LP Shunt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-12-21', 'studyFirstSubmitQcDate': '2021-12-21', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures', 'timeFrame': '9 months', 'description': 'Risk factors associated with post-induction hypotension after administration of anesthetic agents'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['The iNPH Patients Scheduled for VP or LP Shunt Procedures']}, 'descriptionModule': {'briefSummary': "This study is a retrospective work involving the review of patients who were scheduled for VP or LP shunt in Siriraj Hospital, Mahidol University, Thailand. The sample size calculation was based on the rule of thumbs of the logistic regression comprising 18 risk factors. The incidence of post-induction hypotension according to our institution's pilot study November 2019-January 2020) was 47%. With 10% addition for missing data and other possible reasons, the sample size was 426. The primary objective of the study is to report the factors associated with post-induction hypotension in iNPH patients undergoing VP or LP shunt procedures. Our secondary objective is to determine the incidence of post-induction hypotension in these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "\\- Elective cases of iNPH scheduled for VP and LP shunt whose medical records were acquired from the hospital's central database.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cases of iNPH scheduled for VP and LP shunt\n* Patients aged \\> 18 years old\n\nExclusion Criteria:\n\n* Emergency cases'}, 'identificationModule': {'nctId': 'NCT05183061', 'briefTitle': 'Factors Associated With Post-induction Hypotension in iNPH Patient Undergoing VP and LP Shunt', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Factors Associated With Post-induction Hypotension in Idiopathic Normal Pressure Hydrocephalus (iNPH) Patient Undergoing Ventriculoperitoneal (VP) and Lumbar Peritoneal (LP) Shunt', 'orgStudyIdInfo': {'id': '961/2563(IRB4)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypotensive group', 'description': 'Hypotenson is defined as systolic blood pressure (SBP) \\< 80 mmHg or a drop more than 20% from baseline SBP for longer than 10 minutes or a drop that requires treatment either vasopressor or inotropic drugs.', 'interventionNames': ['Drug: Ehedrine Norepineprine']}, {'label': 'Non-hypotensive group', 'description': 'The pateints who did not develop hypotensive episodes as aforementioned.'}], 'interventions': [{'name': 'Ehedrine Norepineprine', 'type': 'DRUG', 'description': 'No interventions required considering that this was a retrospective study.', 'armGroupLabels': ['Hypotensive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Anesthesiology Department', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Phuriphong Songarj', 'investigatorAffiliation': 'Mahidol University'}}}}