Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-03 @ 8:17 PM
Study NCT ID:
NCT05549050
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2022-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2022-09-17', 'studyFirstSubmitQcDate': '2022-09-17', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing hemodialysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['interdialytic weight gain', 'cardiovascular', 'chronic kidney disease', 'hemodialysis'], 'conditions': ['End Stage Renal Disease on Dialysis']}, 'descriptionModule': {'briefSummary': 'This study aimed to discuss the correlation between interdialytic weight gain and cardiovascular diseases in children with end-stage kidney disease undergoing chronic hemodialysis. The cardiovascular parameters used include left ventricular hypertrophy, systolic and diastolic function, carotid intima-media thickness, myocardial circumferential strain, and strain rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'End-stage kidney disease children aged 2-18 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage kidney disease (chronic kidney disease stage 5)\n* Undergo hemodialysis at least twice a week\n\nExclusion Criteria:\n\n* History of congenital heart disease\n* Critically ill patients with unstable hemodynamic status'}, 'identificationModule': {'nctId': 'NCT05549050', 'briefTitle': 'Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Correlation Between Interdialytic Weight Gain and Cardiovascular Diseases in Children With End-Stage Kidney Disease Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': '21-10-1072'}}, 'armsInterventionsModule': {'interventions': [{'name': 'interdialytic weight gain', 'type': 'OTHER', 'description': 'interdialytic weight gain during hemodialysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Henny A Puspitasari, dr. Sp.A(K)', 'role': 'CONTACT', 'email': 'henny.adriani.01@ui.ac.id', 'phone': '+6281218603930'}], 'facility': 'Cipto Mangunkusumo Hospital', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Henny A Puspitasari, dr. Sp.A(K)', 'role': 'CONTACT', 'email': 'henny.adriani01@ui.ac.id', 'phone': '+6281218603930'}, {'name': 'Callen Zulkifli, dr.', 'role': 'CONTACT', 'email': 'callen@alumni.ui.ac.id', 'phone': '+6285966795947'}], 'overallOfficials': [{'name': 'Henny A Puspitasari, dr. Sp.A(K)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Child Health, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant of Pediatric Nephrology', 'investigatorFullName': 'Henny Adriani Puspitasari', 'investigatorAffiliation': 'Indonesia University'}}}}