Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-20 @ 7:53 PM
Study NCT ID:
NCT02588794
Status:
UNKNOWN
Last Update Posted:
2015-10-28
First Post:
2015-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cytokine Adsorption in Sepsis and Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-27', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RIFLE stadium L or E after acute kidney injury related to sepsis', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '3 months'}, {'measure': 'length of renal replacement therapy', 'timeFrame': '3 months'}, {'measure': 'SOFA score', 'timeFrame': '3 months'}, {'measure': 'cumulative dose of vasopressor support', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sepsis, acute kidney injury , CytoSorb'], 'conditions': ['Renal Insufficiency or Renal Failure &or End-stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney injury in patients with severe sepsis/septic shock', 'detailedDescription': 'Patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (RIFLE I) or kidney failure (RIFLE F), were randomized in two groups.\n\nOne group is treated with CVVHD/ local citrat anticoagulation (standart clinical practice).\n\nThe other group ist treated with an additional cytokine adsorber ( 300ml CytoSorb device, 3804606CE01)\n\nCytoSorb therapy is performed for 24h, then the adsorber is changed into a new device.\n\nCytosorb therapy is stopped, when Interleukin 6 leves drop below 1000 pg/ml in patient serum.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe sepsis or septic shock according to ESICM guidelines not older than 24 h\n\nExclusion Criteria:\n\n* preexisting renal disease KDIGO stadium 4 and 5'}, 'identificationModule': {'nctId': 'NCT02588794', 'acronym': 'CASAKI', 'briefTitle': 'Cytokine Adsorption in Sepsis and Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Cytokine Adsorption in Sepsis and Acute Kidney Injury', 'orgStudyIdInfo': {'id': '316/15 S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention', 'description': 'Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)', 'interventionNames': ['Device: CytoSorb 300 ml device (3804606CE01)']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Standart CVVHD'}], 'interventions': [{'name': 'CytoSorb 300 ml device (3804606CE01)', 'type': 'DEVICE', 'description': 'additional cytokine adsorber', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralph Bogdanski, MD', 'role': 'CONTACT', 'email': 'ralph.bogdanski@tum.de', 'phone': '+498941405472'}, {'name': 'Barbara Kapfer, MD', 'role': 'CONTACT', 'email': 'b.kapfer@tum.de', 'phone': '+498941405473'}, {'name': 'Markus Heim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Günther Edenharter, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik für Anästhesiologie', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}], 'centralContacts': [{'name': 'Ralph Bogdanski, MD', 'role': 'CONTACT', 'email': 'ralph.bogdanski@tum.de', 'phone': '+498941405472'}, {'name': 'Barbara Kapfer, MD', 'role': 'CONTACT', 'email': 'b.kapfer@tum.de', 'phone': '+498941405473'}], 'overallOfficials': [{'name': 'Kochs Eberhard, Chairman', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthsiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.', 'investigatorFullName': 'Guenther_Edenharter', 'investigatorAffiliation': 'Technical University of Munich'}}}}