Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-07 @ 7:27 AM
Study NCT ID:
NCT02399358
Status:
UNKNOWN
Last Update Posted:
2015-12-17
First Post:
2015-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-16', 'studyFirstSubmitDate': '2015-03-22', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyponatremia', 'timeFrame': 'Between 6 and 8 hours after the infusion of cyclophosphamide is performed.', 'description': 'Hyponatremia, measured as any value sodium after infusion and defined as positive if sodium less than 135 mEq / l (Yes / No, dichotomous categorical variable). For the incidence of hyponatremia is only included in the calculation hionatremia patients with normal sodium before infusion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug induced Hyponatremia', 'Cyclophosphamide', 'Hyponatremia', 'Cyclophosphamide induced Hyponatremia'], 'conditions': ['Hyponatremia']}, 'descriptionModule': {'briefSummary': 'Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.', 'detailedDescription': 'Primary objectives\n\n1. To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more).\n2. Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide.\n3. To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide.\n\nStudy design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (Over 18 years) admitted for high-dose cyclophosphamide.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017.\n\nExclusion Criteria:\n\n* Refusal to participate or to the process of informed consent.'}, 'identificationModule': {'nctId': 'NCT02399358', 'briefTitle': 'Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Italiano de Buenos Aires'}, 'officialTitle': 'Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study', 'orgStudyIdInfo': {'id': '2439'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High-dose Cyclophosphamide', 'description': 'Patients requiring infusion of high-dose cyclophosphamide in the period 2015-2017 will be included. After informed consent, patients will de follow up from the infusion of cyclophosphamide to 30 days after hospital discharge.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1199ABB', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'contacts': [{'name': 'Diego H Giunta, MD', 'role': 'CONTACT', 'email': 'diego.giunta@hospitalitaliano.org.ar', 'phone': '+54 9 11 5825-6489'}, {'name': 'Cristina M Elizondo, MD', 'role': 'CONTACT', 'email': 'cristina.elizondo@hospitalitaliano.org.ar', 'phone': '+54 9 11 5745-8048'}], 'facility': 'Hospital Italiano de Buenos Aires, Peron 4190', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'centralContacts': [{'name': 'Fernando Warley, MD', 'role': 'CONTACT', 'email': 'fernando.warley@hospitalitaliano.org.ar', 'phone': '+54 9 11 61541958'}, {'name': 'Belen Bonella, MD', 'role': 'CONTACT', 'email': 'maria.bonella@hospitalitaliano.org.ar', 'phone': '+54 9 11 21620279'}], 'overallOfficials': [{'name': 'Fernando Warley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Belen Bonella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Victoria Otero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}, {'name': 'Bruno L Ferreyro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Italiano de Buenos Aires'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diego Hernan Giunta, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Diego Hernan Giunta, MD', 'investigatorAffiliation': 'Hospital Italiano de Buenos Aires'}}}}