Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05884905
Status:
UNKNOWN
Last Update Posted:
2023-06-01
First Post:
2023-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-04-30', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal dysfunction at least grade 1 following cisplatin treatment in short hydration group', 'timeFrame': 'from starting cisplatin to 4-week after cisplatin discontinuation', 'description': 'increased serum creatinine of 0.3 mg/dl or serum creatinine \\>= 1.5-2x upper normal limit'}], 'secondaryOutcomes': [{'measure': 'renal dysfunction >= grade 2 following cisplatin treatment in short hydration group', 'timeFrame': 'from starting cisplatin to 4-week after cisplatin discontinuation', 'description': 'serum creatinine \\> 2-3x upper normal limit'}, {'measure': 'rate of cisplatin modification due to adverse effects in short hydration group', 'timeFrame': 'from starting cisplatin to 4-week after cisplatin discontinuation', 'description': 'delay or dose reduction or discontinuation of cisplatin due to adverse effect'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['renal impairment', 'cisplatin', 'hydration protocol'], 'conditions': ['Renal Insufficiency', 'Cis-Platinum Nephropathy']}, 'referencesModule': {'references': [{'pmid': '39819128', 'type': 'DERIVED', 'citation': 'Jantarat A, Thamlikitkul L, Thephamongkhol K, Setakornnukul J, Phisalprapa P, Kositamongkol C, Srithongkul T, Ithimakin S. Efficacy and Safety of Short Intravenous Hydration for Preventing Nephrotoxicity From High-Dose Cisplatin: A Randomized, Open-Label, Phase II Trial. JCO Glob Oncol. 2025 Jan;11:e2400515. doi: 10.1200/GO-24-00515. Epub 2025 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patient who has plan to receive first cycle of cisplatin \\>= 60 mg/m2\n* Normal serum creatinine and creatinine clearance \\>= 50 ml/min\n* Age \\< 75 years old\n* Serum albumin \\>= 3 g/dl\n* Plan to receive optimal antiemetic regimen consisting of olanzapine or neurokinase 1 receptor antagonist\n\nExclusion Criteria:\n\n* The patient who receives other chemotherapy with adminstration volume higher than 500 ml\n* Prior heart failure or known left ventricular ejection fraction \\> 50%\n* Prior renal dysfunction within 3 months\n* Uncontrolled renal disease\n* current use of diuretic or non-steroidal anti-inflammatory drug (NSAIDs) or starting angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockade (ARB) within 3 months'}, 'identificationModule': {'nctId': 'NCT05884905', 'briefTitle': 'Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Randomized Study Evaluating Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration', 'orgStudyIdInfo': {'id': 'si186/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'short hydration', 'description': 'Normal saline (NSS) 500 ml infusion in 1 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 500 ml infusion in 1 hour, then NSS 500 ml infusion in 2 hours', 'interventionNames': ['Procedure: short hydration']}, {'type': 'OTHER', 'label': 'conventional hydration', 'description': 'NSS 1000 ml infusion in 8 hour cisplatin in NSS 100 ml with 20% mannitol 100 ml infusion in 1 hour other chemotherapy infusion in 1 hour (if available) NSS 2000 ml infusion in 16 hour', 'interventionNames': ['Procedure: conventional hydration']}], 'interventions': [{'name': 'short hydration', 'type': 'PROCEDURE', 'otherNames': ['short intravenous fluid infusion'], 'description': 'NSS infusion prior to and following cisplatin administration within 6 hours', 'armGroupLabels': ['short hydration']}, {'name': 'conventional hydration', 'type': 'PROCEDURE', 'otherNames': ['long intravenous fluid infusion'], 'description': 'NSS infusion prior to and following cisplatin administration over 24 hours', 'armGroupLabels': ['conventional hydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10260', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suthinee Ithimakin', 'role': 'CONTACT', 'email': 'aesi105@yahoo.co.th', 'phone': '0898127440'}], 'facility': 'Faculty of Medicine Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Suthinee Ithimakin, MD', 'role': 'CONTACT', 'email': 'aesi105@yahoo.co.th', 'phone': '+66898127440'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Siriraj Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}