Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-26 @ 3:35 PM
Study NCT ID:
NCT01838759
Status:
COMPLETED
Last Update Posted:
2014-11-03
First Post:
2013-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}, {'id': 'D004487', 'term': 'Edema'}, {'id': 'D020896', 'term': 'Hypovolemia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2013-04-20', 'studyFirstSubmitQcDate': '2013-04-20', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of volume status measured by bioimpedance spectroscopy', 'timeFrame': 'Six months', 'description': 'BIOIMPEDANCE SPECTROSCOPY:\n\nOverhydration (OH) measurement by Body Composition Monitor (Fresenius Medical Care)\n\nNegative values of "OH" indicating Hypovolemia and positive values for hypervolemia in hyponatremic patients.'}], 'secondaryOutcomes': [{'measure': 'Laboratory data and echocardiography', 'timeFrame': '6 Months', 'description': 'LABORATORY MEASUREMENTS Hemoglobin, Hematocrit, White blood cell count Platelet count, Na, Potassium, Chlorur, Urea, Creatinine, Uric acid, Plasma osmolality, Urine osmolality, Alanine transaminase , Aspartate transaminase , Urine specific gravity,\n\nTREATMENT MODALITY\n\n1. Diuretics\n2. Intravenous hydration by isotonic saline\n\nECHOCARDIOGRAPHY:\n\nLeft ventricular end-diastolic diameter, Left ventricular end-systolic diameter, Ejection fraction(%), Left Atrium diameter, Aortic diameter, Right atrium diameter, Interventricular septum, Posterior wall thickness, Mitral insufficiency, Pulmonary insufficiency, Systolic pulmonary artery pressure, Tricuspid insufficiency'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioimpedance spectroscopy', 'Hypervolemia', 'Hypovolemia'], 'conditions': ['Hyponatremia']}, 'referencesModule': {'references': [{'pmid': '23415416', 'type': 'BACKGROUND', 'citation': 'Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15.'}, {'pmid': '25915455', 'type': 'DERIVED', 'citation': 'Kose SB, Hur E, Magden K, Yildiz G, Colak D, Kucuk E, Toka B, Kucuk H, Yildirim I, Kokturk F, Duman S. Bioimpedance spectroscopy for the differential diagnosis of hyponatremia. Ren Fail. 2015 Jul;37(6):947-50. doi: 10.3109/0886022X.2015.1040418. Epub 2015 Apr 27.'}]}, 'descriptionModule': {'briefSummary': 'We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia', 'detailedDescription': '* Up to now, "Hyponatremia" differentially diagnosed by physical examination, plasma and urine osmolalities, Echocardiography and biochemical measurements.\n* The purpose of this study is to determine whether bioimpedance spectroscopy can be used for the detection of hypovolemia and hypervolemia for the differential diagnosis of hyponatremia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to Bulent Ecevit University Hospital with the presentation of hyponatremia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to participate in the study with written informed consent\n* Older than 18-years\n\nExclusion Criteria:\n\n* The presence of pacemaker or defibrillator\n* Artificial joints, pin or amputation\n* Pregnancy or lactating.'}, 'identificationModule': {'nctId': 'NCT01838759', 'briefTitle': 'Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia', 'orgStudyIdInfo': {'id': 'BEUN 2013-31-26/02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypovolemic hyponatremia', 'description': 'Negative values of "Overhydration" measured by Bioimpedance spectroscopy'}, {'label': 'Hypervolemic hyponatremia', 'description': 'Positive values of "Overhydration" measured by Bioimpedance spectroscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67300', 'city': 'Zonguldak', 'country': 'Turkey (Türkiye)', 'facility': 'Bulent Ecevit University Hospital', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}], 'overallOfficials': [{'name': 'Ender Hur, Assoc.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Ender Hur', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}