Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 6:02 PM
Study NCT ID:
NCT00483912
Status:
SUSPENDED
Last Update Posted:
2007-06-08
First Post:
2007-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Albumindialysis in Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-07', 'studyFirstSubmitDate': '2007-06-07', 'studyFirstSubmitQcDate': '2007-06-07', 'lastUpdatePostDateStruct': {'date': '2007-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-08', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pancreatitis, MARS', 'severe acute pancreatitis with early multiple organ failure'], 'conditions': ['Pancreatitis', 'Multiple Organ Failure']}, 'descriptionModule': {'briefSummary': 'The incidence of acute pancreatitis has been doubled during last three decades in Finland. Alcohol is the main cause of acute pancreatitis in Finland accounting for 70 % of cases. Although the mortality of acute pancreatitis has been decreased it still appears and especially early multiple organ failure is the main cause of all deaths. Multiple organ failure in the early course of the disease is thought to be caused by the release of cytokines. Molecular adsorbent recirculating system (MARS) has shown to decrease mortality in acute alcohol hepatitis and paracetamol intoxication. Also it has been shown to improve kidney function due to hypoperfusion and tubulus necrosis and overrule decrease mortality in patients with multiple organ failure due to different reasons. A part of patients with acute alcoholic pancreatitis may have so-called fat liver already on admission. It has been shown that the highest mortality is especially associated those with early liver and kidney failure. MARS treatment has never earlier been used in the patients with acute alcoholic pancreatitis and early organ failure. In this study we randomize patients with acute alcoholic pancreatitis and early multiple organ failure (Sofa score\\>2) to two groups: 1) Standard pancreatitis treatment in intensive care unit and 2) Standard pancreatitis treatment in intensive care unit with 5 MARS sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe acute alcoholic pancreatitis with early multiple organ failure (Sofa score \\>2)\n\nExclusion Criteria:\n\n* If patient or his/her family member refuses, pregnancy.'}, 'identificationModule': {'nctId': 'NCT00483912', 'acronym': 'pancreatitis', 'briefTitle': 'Albumindialysis in Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University'}, 'officialTitle': 'Molecular Adsorbent Recirculating System (MARS) in Severe Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'R04005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Molecular adsorbent recirculating system', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Sari Räty', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Gastroenterology and Alimentary Tract Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University', 'class': 'OTHER'}}}}