Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01201720
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2010-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010951', 'term': 'Plasma Exchange'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010956', 'term': 'Plasmapheresis'}, {'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-05', 'studyFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2010-09-14', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Albumin functional capacity', 'timeFrame': '10 days', 'description': 'Albumin binding capacity'}, {'measure': 'Albumin functional capacity', 'timeFrame': '10 days', 'description': 'Electron Paramagnetic Resonance Spectroscopy'}, {'measure': 'Albumin functional capacity', 'timeFrame': '10 days', 'description': 'Ischemia-modified albumin'}, {'measure': 'Circulatory disfunction', 'timeFrame': '10 days', 'description': 'Plasma renin activity'}, {'measure': 'Circulatory disfunction', 'timeFrame': '10 days', 'description': 'Plasma concentration of noradrenaline'}, {'measure': 'Circulatory disfunction', 'timeFrame': '11 days', 'description': 'Systemic hemodynamic study and portal venous pressure'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of blood urea nitrogen', 'timeFrame': '1 month'}, {'measure': 'Hepatic encephalopathy graded with the West Haven Criteria', 'timeFrame': '1 month'}, {'measure': 'Hepatic function parameters', 'timeFrame': '1 month', 'description': 'Conventional hepatic function parameters: aspartate transaminase, alanine transaminase, gamma-glutamyl transferase, alkaline phosphatase, total, conjugated and not conjugated serum bilirubin, serum albumin, international normalized ratio (INR) and prothrombin index'}, {'measure': 'Plasma concentration of serum creatinine', 'timeFrame': '1 month'}, {'measure': 'Plasma concentration of sodium', 'timeFrame': '1 month'}, {'measure': 'Plasma concentration of potassium', 'timeFrame': '1 month'}, {'measure': 'Plasma concentration of phosphorus', 'timeFrame': '1 month'}, {'measure': 'hepatic toxins', 'timeFrame': '10 days', 'description': 'Hepatic toxin concentration: biliary acids, aromatic amino acids, ammonium and lactatum.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cirrhosis', 'cirrhotic patients with acute on chronic liver failure'], 'conditions': ['Liver Cirrhosis', 'Liver Failure']}, 'referencesModule': {'references': [{'pmid': '38544553', 'type': 'DERIVED', 'citation': 'Fernandez J, Lozano M, Torres M, Horrillo R, Afonso N, Nunez L, Mestre A, Perez A, Cid J, Costa M, Arroyo V, Paez A. Effect of plasma exchange with albumin replacement on albumin functionality and organ dysfunction in acute-on-chronic liver failure. JHEP Rep. 2024 Jan 22;6(4):101017. doi: 10.1016/j.jhepr.2024.101017. eCollection 2024 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure".', 'detailedDescription': 'The purpose of this study is to evaluate the effects on plasma exchange with 5% albumin on albumin functional capacity, cardiocirculatory, renal and cerebral function in cirrhotic patients with "acute-on-chronic liver failure", renal disfunction, cerebral disfunction ,and inflamtory response'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 80 years old\n* Hepatic cirrhosis diagnosed by biopsy or clinical, analytic and ultra sound data.\n* acute on chronic liver failure: defined by an acute deterioration in hepatic function produced in 2-4 weeks with jaundice (total serum bilirubin ≥ 5 mg/dl ) and hepatic encephalopathy (≥ grade 2) and/or renal insufficiency (serum creatinine ≥ 2 mg/dl)\n\nExclusion Criteria:\n\n* Neoplasm disease including hepatocarcinoma which exceed Milan criteria (1 tumour \\> 5cm, up to 3 tumours \\<3 cm)\n* Active bacterial or fungal infection with hemodynamic instability which require the utilization of vasoactive drugs at moderate dose (\\>0,5 μg/Kg/min of noradrenaline)\n* Structural moderate to severe cardiopathy (Cardiac Index \\<2l/min/m2)\n* Chronic renal insufficiency in treatment with haemodialysis\n* Chronic moderate o severe pulmonary disease (maximum expiratory volume in a second \\<50%)\n* Active transplant\n* human immunodeficiency virus infection\n* Pregnancy or lactation\n* Acute respiratory distress syndrome (P02/Fi02\\< 200mm Hg) or acute lung injury (P02/Fi02\\< 300mm Hg)\n* Hemodynamic instability (\\>0,5 μg/Kg/min of noradrenaline)\n* Bleeding in the digestive tract in the previous 72h to the treatment\n* Severe coagulopathy: INR ≥ 3.0 (Quick ≤ 20%) and/or platelets \\< 30000//mm3\n* Extrahepatic cholestasis\n* Hepatobiliary surgery in the last 6 months (except laparoscopic Cholecystectomy)\n* Concentrations bilirubin ≥ 5mg/dl during the period above 4 weeks previous to inclusion\n* Concomitant participation in an other clinical trial\n* Drug addiction\n* Mental status which does not allow the patient to understand the trial, with the exception of hepatic encephalopathy.'}, 'identificationModule': {'nctId': 'NCT01201720', 'briefTitle': 'Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Dysfunction, Renal and Cerebral Function in Cirrhotic Patients With "Acute-on-chronic Liver Failure"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': 'Effects on Plasma Exchange on Functional Capacity of Serum Albumin, Circulatory Liver Failure"', 'orgStudyIdInfo': {'id': 'IG0905'}, 'secondaryIdInfos': [{'id': '2010-021360-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Albumin', 'description': 'Albumin solution for infusion 5%. dosage: 43,5 millimole intravenouse use , 6 plasma exchange with albumin in 11 days and administration of polyclonal gamma globulin.6 sessions', 'interventionNames': ['Procedure: Plasma exchange with albumin']}], 'interventions': [{'name': 'Plasma exchange with albumin', 'type': 'PROCEDURE', 'otherNames': ['Albumina grifols 5%'], 'description': 'Realization of 6 plasma exchange with albumin in 11 days', 'armGroupLabels': ['Albumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic of Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Vicente Arroyo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Grifols, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}