Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-31 @ 4:04 PM
Study NCT ID:
NCT03901794
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fluid removed along with hemodialysis', 'timeFrame': '4 hours', 'description': 'the fluid volume removed from hemodialysis (mL/hour),'}, {'measure': 'changes of mean arterial pressure along with hemodialysis', 'timeFrame': '4 hours', 'description': 'record of mean arterial pressure (mmHg) per 30 minutes'}, {'measure': 'changes of heart rate along with hemodialysis', 'timeFrame': '4 hours', 'description': 'record of heart rate (beats/ minute) per 30 minutes'}, {'measure': 'changes of stroke volume along with hemodialysis', 'timeFrame': '4 hours', 'description': 'record of stroke volume (SV, (mL/ beat)per 30 minutes'}, {'measure': 'changes of cardiac output along with hemodialysis', 'timeFrame': '4 hours', 'description': 'record of cardiac output ( liter/ minute)per 30 minutes'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemodialysis Complication', 'Hemodialysis-Induced Symptom']}, 'referencesModule': {'references': [{'pmid': '35574491', 'type': 'DERIVED', 'citation': 'Lai CJ, Shih CC, Huang HH, Chien MH, Wu MS, Cheng YJ. Detecting Volemic, Cardiac, and Autonomic Responses From Hypervolemia to Normovolemia via Non-Invasive ClearSight Hemodynamic Monitoring During Hemodialysis: An Observational Investigation. Front Physiol. 2022 Apr 28;13:775631. doi: 10.3389/fphys.2022.775631. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Relationship between hemodynamic change and fluid removed during hemodialysis measured by non-invasive monitor', 'detailedDescription': 'By applying non-invasive hemodynamic monitors (ex. ClearSight, I-COM), the trends of mean arterial pressure (MAP), stroke volume (SV), cardiac index (CI) and calculated systemic vascular resistance (SVR) were collected along with volume removal by hemodialysis on ESRD patients. All data were compared and analyzed to detect the sequential body volume status as well as the autonomic responses during hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'end-stage renal disease patients who were under regular hemodialysis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1\\. Patients who were schedured with regular hemodialysis for end-stage renal disease.\n\nExclusion criteria:\n\n1. Emergent hemodialysis\n2. Medical conditions with poor peripheral circulation such as Raynaud's disease or PAOD\n3. Skin defects or wounds over area to be applied for measurement (Wrist and fingers)"}, 'identificationModule': {'nctId': 'NCT03901794', 'briefTitle': 'Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Relationship Between Hemodynamic Change and Fluid Removed During Hemodialysis Measured by Non-invasive Monitor', 'orgStudyIdInfo': {'id': '201702064RIPB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With Clear Sight', 'description': 'record and observe the data including SVI, CI, SVR with clearSight during hemodialysis', 'interventionNames': ['Device: Non-invasive hemodynamic monitor']}], 'interventions': [{'name': 'Non-invasive hemodynamic monitor', 'type': 'DEVICE', 'description': 'MAP, HR, CO, SVI, from Non-invasive hemodynamic monitor', 'armGroupLabels': ['With Clear Sight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'ST Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}