Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT01872793
Status:
COMPLETED
Last Update Posted:
2016-10-10
First Post:
2013-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of BIVA for Nutritional Assessment in Cirrhotic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of mortality', 'timeFrame': 'Through study completion, an average of 36 months.'}], 'primaryOutcomes': [{'measure': 'Changes in nutritional status', 'timeFrame': 'At the time of inclusion, every six months up to 36 months', 'description': 'It will be assessed by bioelectrical impedance vector analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioelectrical impedance vector analysis', 'nutritional assessment', 'nutritional status', 'mortality', 'complications'], 'conditions': ['Liver Cirrhosis', 'Malnutrition']}, 'descriptionModule': {'briefSummary': "Despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. Traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure.\n\nBioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.).\n\nWith previous results from our research group, BIVA showed to be useful for evaluating cirrhotic patients.\n\nThe aim of this study is to validate our previous results and validate BIVA for nutritional assessment in patients with liver cirrhosis"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants will be recruited from the Gastroenterology Department of a tertiary care setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnose of liver cirrhosis by two or more of the following criteria:\n\n* Albumin \\< 3.4 g/dL\n* INR ≥ 1.3\n* Total bilirubin ≥ 2 mg/dL\n* Portal hypertension (esophageal varices, splenomegaly, ascites, etc.)\n* Liver biopsy\n* Ambulatory patients\n\nExclusion Criteria:\n\n* Personal history of surgery in the last four weeks\n* Thyroid disorders without replacement therapy\n* Pregnancy\n* Active alcoholism with alcohol ingest in the previous 6 months.\n* Acute or chronic renal failure\n* Hepatic or renal transplant'}, 'identificationModule': {'nctId': 'NCT01872793', 'briefTitle': 'Validation of BIVA for Nutritional Assessment in Cirrhotic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Validation of Bioelectrical Impedance Vector Analysis for Nutritional Assessment in Patients With Cirrhosis', 'orgStudyIdInfo': {'id': 'BIVA02'}}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Aldo Torre, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"'}, {'name': 'Astrid Ruiz-Margain, BSc, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, {'name': 'Ricardo Macías-Rodriguez, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., M.Sc.', 'investigatorFullName': 'ALDO TORRE DELGADILLO', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}