Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT01079104
Status:
TERMINATED
Last Update Posted:
2019-07-09
First Post:
2010-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'The foundations of our pilotstudy planning has changed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality rate', 'timeFrame': '30 days', 'description': 'Mortality 30 days after the first intervention'}], 'secondaryOutcomes': [{'measure': 'Multiorgan system failure according to the Sequential Organ Failure Assessment (SOFA) Score', 'timeFrame': '72 hours', 'description': 'The Sequential Organ Failure Assessment (SOFA) Score analyses the severity of illness according to 6 organ systems (CNS, Liver, Kidney, Hemodynamic, Coagulation, Lung). Each system is given 0 to 4 points for a total of 24 points. A value \\>2 in each of the systems indicates organ failure. An overall value \\> 14 indicates 90% probability of in-hospital mortality.'}, {'measure': 'Adverse Events', 'timeFrame': '30 days', 'description': 'Adverse Events during the intervention will be assessed'}, {'measure': 'Number of days on ventilation', 'timeFrame': '30 days', 'description': 'Number of days with need of mechanical ventilation after first intervention'}, {'measure': 'Number of days without extracorporeal treatment', 'timeFrame': '30 days', 'description': 'Number of days without the need of extracorporeal renal and/or liver replacement therapy after the first intervention'}, {'measure': '180d-mortality rate', 'timeFrame': '180 days', 'description': 'Mortality 180 days after the first intervention'}, {'measure': '1y-mortality rate', 'timeFrame': '1 year', 'description': 'Mortality 1 year after the first intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver failure', 'Hepatic insufficiency', 'Artificial liver', 'Albumin dialysis'], 'conditions': ['Liver Dysfunction', 'Critical Illness']}, 'referencesModule': {'references': [{'pmid': '28209134', 'type': 'RESULT', 'citation': 'Huber W, Henschel B, Schmid R, Al-Chalabi A. First clinical experience in 14 patients treated with ADVOS: a study on feasibility, safety and efficacy of a new type of albumin dialysis. BMC Gastroenterol. 2017 Feb 16;17(1):32. doi: 10.1186/s12876-017-0569-x.'}]}, 'descriptionModule': {'briefSummary': 'Patients with hepatic dysfunction are known to have a high mortality rate. Hepa Wash(R) is a newly developed liver and renal support system that is based on the use of recycled albumin dialysate. The new system has shown a high detoxification capacity in in-vitro and preclinical studies. The aim of the study is to evaluate the safety and efficacy of the Hepa Wash system in patients with hepatic dysfunction in the intensive care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Bilirubin ≥ 2 mg/dl AND\n2. SOFA-score ≥ 9 calculated 12 hours after initiating medical resuscitation measures AND\n3. Patient is in the intensive care unit AND\n4. Signed informed consent of the patient or legal representative AND\n5. Patients are 18 years or older AND\n6. Enrollment of patients within 96 hours of fulfilling inclusion criteria (1-3).\n\nExclusion Criteria:\n\n1. Patient with known history of chronic liver disease\n2. Untreatable extrahepatic cholestasis\n3. Patient has a survival prognosis of less than 6 weeks because of a chronic disease (e.g. metastasizing cancer) and before the acute event which lead to the ICU admission.\n4. PaO2/FIO2 ≤ 100 mmHg\n5. Patients on kidney dialysis\n6. Patients with MELD-score of 40\n7. Mean arterial pressure ≤ 50 mmHg despite conventional medical treatment\n8. Patient testament excludes the use of life-prolonging measures\n9. Post-operative patients whose liver failure is related to liver surgery\n10. Uncontrolled seizures\n11. Active or uncontrolled bleeding\n12. Weight ≥ 120 kg\n13. Pregnancy\n14. Patient diagnosed with Creutzfeldt-Jakob disease\n15. Participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT01079104', 'acronym': 'HEPATICUS-2', 'briefTitle': 'Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hepa Wash GmbH'}, 'officialTitle': 'Hepa Wash Treatment of Patients With Hepatic Dysfunction in Intensive Care Units', 'orgStudyIdInfo': {'id': 'CS002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard Medical Therapy', 'interventionNames': ['Procedure: Standard Medical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Hepa Wash', 'description': 'Treatment with the liver support system "Hepa Wash"', 'interventionNames': ['Device: Hepa Wash']}], 'interventions': [{'name': 'Hepa Wash', 'type': 'DEVICE', 'otherNames': ['Hepa Wash procedure', 'the HIP1001 system'], 'description': 'Intervention frequency: 1-10 treatments (decision of the investigator)\n\nDuration of intervention per patient: Treatment until recovery or death (max. 6 weeks)', 'armGroupLabels': ['Hepa Wash']}, {'name': 'Standard Medical Therapy', 'type': 'PROCEDURE', 'description': 'Standard of care treatment', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'II Medizinische Klinik, Klinikum rechts der Isar', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Wolfgang Huber, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'II Medizinische Klinik, Klinikum rechts der Isar, Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepa Wash GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}