Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-02-18 @ 6:49 AM
Study NCT ID:
NCT02022150
Status:
UNKNOWN
Last Update Posted:
2019-02-01
First Post:
2013-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body Composition Analysis in Cirrhotic Undergoing Paracentesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D001201', 'term': 'Ascites'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001823', 'term': 'Body Composition'}, {'id': 'D019152', 'term': 'Paracentesis'}], 'ancestors': [{'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2013-01-17', 'studyFirstSubmitQcDate': '2013-12-20', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Baseline and 8 days post treatment', 'description': 'bioelectrical impedance vector analysis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Paracentesis', 'Liver Cirrhosis', 'ascites', 'body composition'], 'conditions': ['Liver Cirrhosis', 'Ascites']}, 'descriptionModule': {'briefSummary': 'Ascites is a frequent complication of liver cirrhosis, initial treatment consists on diuretics intake, however, as the disease progresses this complication becomes more severe, consequently other therapeutic options are used.\n\nParacentesis is indicated when severe ascites is present and it should be accompanied by albumin infusion.\n\nNutritional status is generally affected in patients with liver cirrhosis, even more patients with severe ascites show decreased energy intake due to gastric compression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The cohort will be selected from the Liver Clinic, Department of Gastroenterology at a tertiary care center in Mexico', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any genre.\n* Age 18-70 years old.\n* Diagnosis of liver cirrhosis of any etiology (documented by clinical, biochemical, radiological and / or biopsy.\n* Presence of high volume ascites\n* The signing of informed consent will be required for the inclusion of any patient.\n\nExclusion Criteria:\n\n* Hepatic encephalopathy grade III or IV. 2) liver transplantation.\n* Congestive heart failure.\n* Hemodialysis.\n* Acute or chronic renal failure.\n* Nephrotic syndrome with protein loss.\n* Alcoholism active in the last 6 months.\n* Pregnancy.\n* upper gastrointestinal bleeding.'}, 'identificationModule': {'nctId': 'NCT02022150', 'acronym': 'Paracentesis', 'briefTitle': 'Body Composition Analysis in Cirrhotic Undergoing Paracentesis', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Body Composition Analysis in Cirrhotic Patients With Ascites Undergoing Paracentesis', 'orgStudyIdInfo': {'id': 'GAS-819-12/13-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Body composition in paracentesis', 'description': 'Taking blood samples and bioelectrical impedance, Psychometric Hepatic Encephalopathy Score (PHES) and Critical Flicker Frequency (CFF) before and after paracentesis.', 'interventionNames': ['Behavioral: Body composition in paracentesis']}], 'interventions': [{'name': 'Body composition in paracentesis', 'type': 'BEHAVIORAL', 'description': 'Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation', 'armGroupLabels': ['Body composition in paracentesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Mexico City', 'state': 'D.F', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Aldo Torre, M.D., M.Sc.', 'role': 'CONTACT', 'email': 'detoal@yahoo.com', 'phone': '54870900', 'phoneExt': '2711'}, {'name': 'Aldo Torre, M.D, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Aldo Torre, M.D, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Aldo Torre, M.D. M.Sci', 'role': 'CONTACT', 'email': 'detoal@yahoo.com', 'phone': '54870900', 'phoneExt': '2709'}], 'overallOfficials': [{'name': 'Aldo Torre, M.D, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Nutrición y Ciencias Médicas "Salvador Zubirán"'}]}, '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'}}}}