Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-04 @ 1:20 AM
Study NCT ID:
NCT03082469
Status:
UNKNOWN
Last Update Posted:
2017-03-17
First Post:
2017-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Inflammatory cytokine removal by Cyto Sorb treatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-10', 'studyFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Haemodynamics', 'timeFrame': 'Within 48h after the onset of CytoSorb treatment', 'description': 'Improvement of the vasopressor dependency index \\>=20%. (Improvement of cardiac power index \\>=20% in case of no vasopressor use at baseline)'}], 'secondaryOutcomes': [{'measure': 'Mortality-1', 'timeFrame': '28 days from inclusion into the study', 'description': '28-days-mortality'}, {'measure': 'Mortality-2', 'timeFrame': 'From admission to the ICU until discharge or transfer from the ICU (up to one year)', 'description': 'ICU-mortality'}, {'measure': 'Mortality-3', 'timeFrame': 'From admission to discharge from the hospital (up to one year)', 'description': 'Hospital-mortality'}, {'measure': 'Inflammation', 'timeFrame': 'Within 48h after the onset of CytoSorb treatment', 'description': 'IL-6, CRP and PCT-values levels compared to before CytoSorb treatment'}, {'measure': 'Respiratory outcome', 'timeFrame': 'Within 28 days after the onset of CytoSorb treatment', 'description': 'Ventilator-free days'}, {'measure': 'Renal function and its Change over time', 'timeFrame': 'Within 28 days after the onset of CytoSorb treatment', 'description': 'Daily classification according to KDIGO; comparison vs. before Cyto Sorb treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe acute pancreatitis', 'Haemodynamic monitoring', 'Cytokine removal', 'Vasopressor dependency index'], 'conditions': ['Pancreatitis, Acute', 'SIRS']}, 'referencesModule': {'references': [{'pmid': '30681551', 'type': 'DERIVED', 'citation': 'Huber W, Algul H, Lahmer T, Mayr U, Lehmann M, Schmid RM, Faltlhauser A. Pancreatitis cytosorbents (CytoSorb) inflammatory cytokine removal: A Prospective Study (PACIFIC). Medicine (Baltimore). 2019 Jan;98(4):e13044. doi: 10.1097/MD.0000000000013044.'}]}, 'descriptionModule': {'briefSummary': 'Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related to the development of SIRS and consecutive organ failures. Due to the lack of a causative therapy except the removal of bile duct stones, therapy is predominantly symptomatic.\n\nWith regard to a marked inflammatory response ("cytokine storm") during the early phase of SAP extracorporeal cytokine removal is a promising therapeutic approach.\n\nThis prospective case control study investigates the impact of early extracorporeal cytokine adsorption with the CytoSorb®-device on haemodynamics (primary endpoint) and several secondary outcomes.', 'detailedDescription': 'Severe acute pancreatitis (SAP) has a mortality of up to 42%. The outcome of SAP is related to the development of SIRS and consecutive organ failures. Due to the lack of a causative therapy except the removal of bile duct stones, therapy is predominantly symptomatic.\n\nSeverity and mortality are associated to an early systemic inflammatory response syndrome (SIRS) and to septic complications at a later stage of disease.\n\nWith regard to a marked inflammatory response ("cytokine storm") during the early phase of SAP extracorporeal cytokine removal is a promising therapeutic approach.\n\nThis prospective case control study investigates the impact of early extracorporeal cytokine adsorption with the CytoSorb® device on haemodynamics (primary endpoint) and several secondary outcomes.\n\nPatients with high probability of SAP (APACHE-II-score ≥10) are eligible for 7 days after the onset of pain.\n\nThe patients will be treated for 48h with two consecutive 24h sessions of cytokine absorption with the CytoSorb®-device.\n\nAll patients will be under haemodynamic Monitoring with transpulmonary thermodilution The primary endpoint is defined as an improvement of the vasopressor dependency index of ≥20% (if no vasoactive drugs are used at baseline, the cardiac power index cardiac power index (CPI) will be used as primary endpoint).\n\nThe outcome analysis will be based on comparison of the incidence of the primary endpoint in 30 Intervention patients compared to 60 matched controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Proven acute pancreatitis:\n\n * typical pain\n * at least 3-fold increase in serum lipase\n * onset of pain within 7 days before inclusion AND\n* APACHE-II ≥10 AND\n* ≥1 criterion of "severe sepsis" AND\n* Haemodynamic monitoring with transpulmonary thermodilution AND\n* ≥ 1 marker of poor prognosis of acute pancreatitis:\n\n * Haematocrit \\> 44% (men), \\>40% (women)\n * Blood glucose \\> 125 mg/dL\n * C-reactive protein (CRP) \\> 10mg/dL\n * Computed tomography score category C-E\n * Age \\>55 years\n * Leukocytes \\>16 G/L\n * Glutamate oxaloacetate transferase (GOT) \\>250 U/L\n * Lactate dehydrogenase (LDH) \\>350 U/L\n * Calcium \\<2,0mmol/L\n\nExclusion Criteria:\n\n* pregnancy\n* lack of informed consent of patient or representative\n* pre-existing disease with life expectancy \\<3 months'}, 'identificationModule': {'nctId': 'NCT03082469', 'acronym': 'PACIFIC', 'briefTitle': 'Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Pancreatitis CytoSorbents (CytoSorb®) Inflammatory Cytokine Removal: A Prospective Study.', 'orgStudyIdInfo': {'id': 'PACIFIC 10-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CytoSorb', 'description': 'CytoSorb therapy for 48h', 'interventionNames': ['Device: CytoSorb']}, {'type': 'NO_INTERVENTION', 'label': 'Matched controls', 'description': '60 matched controls with SAP and transpulmonary thermodilution monitoring'}], 'interventions': [{'name': 'CytoSorb', 'type': 'DEVICE', 'description': 'Two consecutive 24h treatments with the CytoSorb-device', 'armGroupLabels': ['CytoSorb']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wolfgang Huber, Professor', 'role': 'CONTACT', 'email': 'Wolfgang.Huber@tum.de', 'phone': '++49-89-4140-5214'}, {'name': 'Tobias Lahmer, MD', 'role': 'CONTACT', 'email': 'Tobias.Lahmer@mri.tum.de', 'phone': '++49-89-4140-9345'}], 'overallOfficials': [{'name': 'Wolfgang Huber, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'II. Medizinische Klinik; Klinikum rechts der Isar; Technische Universität München'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'CytoSorbents Europe GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. Wolfgang Huber', 'investigatorFullName': 'Wolfgang Huber', 'investigatorAffiliation': 'Technical University of Munich'}}}}