Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 11:32 AM
Study NCT ID:
NCT04013269
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2019-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Therapy With CytoSorb in Refractory Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-06', 'studyFirstSubmitDate': '2019-06-15', 'studyFirstSubmitQcDate': '2019-07-07', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 48 hours of treatment', 'timeFrame': '48 hours', 'description': 'Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in organ dysfunction', 'timeFrame': '10 days', 'description': 'Change in organ dysfunction based on "Sequential Organ Failure Assessment" (SOFA) Score The SOFA score is made of 6 variables, each representing an organ system. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure) The worst physiological variables were collected serially every 24 hours of a patient\'s ICU admission. The "worst" measurement was defined as the measure that correlated to the highest number of points. The SOFA score ranges from 0 to 24.'}, {'measure': 'Lactate clearance', 'timeFrame': '10 days', 'description': 'Improving lactate clearance by lowering serum lactate levels'}, {'measure': 'Renal replacement therapy', 'timeFrame': '10 days', 'description': 'Time with need for renal replacement therapy'}, {'measure': 'Percentage of patients with a reduction of catecholamine dose of at least 25% within the first 24 hours of treatment', 'timeFrame': '24 hours', 'description': 'Percentage of patients with a reduction of catecholamine dose of at least 25% compared to baseline for at least 6 hours within the first 48 hours of treatment.'}, {'measure': 'End of septic shock', 'timeFrame': '10 days', 'description': 'Time until shock resolution'}, {'measure': 'ICU length of stay', 'timeFrame': '90 days', 'description': 'ICU length of stay'}, {'measure': 'Time on mechanical ventilation', 'timeFrame': '10 days', 'description': 'Time on mechanical ventilation'}, {'measure': 'Cumulative catecholamine dose', 'timeFrame': '10 days', 'description': 'Cumulative catecholamine dose'}, {'measure': 'Overall and ICU mortality', 'timeFrame': '90 days', 'description': 'Overall and ICU mortality'}, {'measure': 'Serum levels of administered anti-infectives', 'timeFrame': '3 days', 'description': 'Serum drug Levels of pre and post filter and adsorber system on day 1-3 while CytoSorb therapy (sampling: t 0, 1, 2, 6, 8, 12, 24 h after CytoSorb initiation)'}, {'measure': 'Change of plasma Interleukin-6 (IL6) level', 'timeFrame': '10 days', 'description': 'Change of plasma Interleukin-6 (IL6) level'}, {'measure': 'Change of plasma Interleukin-10 (IL10) level', 'timeFrame': '10 days', 'description': 'Change of plasma Interleukin-10 (IL10) level'}, {'measure': 'Change of plasma Procalcitonin (PCT) level', 'timeFrame': '10 days', 'description': 'Change of plasma Procalcitonin (PCT) level'}, {'measure': 'Change of HLA-DR level', 'timeFrame': '10 days', 'description': 'Change of HLA-DR (Human Leukocyte Antigen - DR isotype) level of monocytes'}, {'measure': 'Change of TNF alpha level after ex-vivo stimulation', 'timeFrame': '10 days', 'description': 'Change of TNF-alfa level (Tumor Necrosis Factor alpha) level after LPS (Lipopolysaccharides) stimulation as sign of monocytic immunocompetence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Critically ill', 'Intensive care medicine', 'CytoSorb', 'Hemoadsorption', 'Pharmacokinetic'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '28537517', 'type': 'BACKGROUND', 'citation': 'Taeb AM, Hooper MH, Marik PE. Sepsis: Current Definition, Pathophysiology, Diagnosis, and Management. Nutr Clin Pract. 2017 Jun;32(3):296-308. doi: 10.1177/0884533617695243. Epub 2017 Mar 17.'}, {'pmid': '28589286', 'type': 'BACKGROUND', 'citation': 'Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.'}, {'pmid': '30481999', 'type': 'BACKGROUND', 'citation': 'Garau I, Marz A, Sehner S, Reuter DA, Reichenspurner H, Zollner C, Kubitz JC. Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor alpha serum levels in cardiac surgery: a randomized controlled trial. Minerva Anestesiol. 2019 Jul;85(7):715-723. doi: 10.23736/S0375-9393.18.12898-7. Epub 2018 Nov 22.'}, {'pmid': '28343448', 'type': 'BACKGROUND', 'citation': 'Kogelmann K, Jarczak D, Scheller M, Druner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. doi: 10.1186/s13054-017-1662-9.'}, {'pmid': '22903091', 'type': 'BACKGROUND', 'citation': 'Bayer O, Reinhart K, Kohl M, Kabisch B, Marshall J, Sakr Y, Bauer M, Hartog C, Schwarzkopf D, Riedemann N. Effects of fluid resuscitation with synthetic colloids or crystalloids alone on shock reversal, fluid balance, and patient outcomes in patients with severe sepsis: a prospective sequential analysis. Crit Care Med. 2012 Sep;40(9):2543-51. doi: 10.1097/CCM.0b013e318258fee7.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized single center study investigates to what extent the removal of elevated cytokine levels by hemoadsorption has a positive effect on the treatment of patients in septic shock by stabilizing the circulatory situation.', 'detailedDescription': 'The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host\'s inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide.\n\nThe clinical picture of septic shock, the most severe form of sepsis, leads to uncontrolled production and release of a large number of proinflammatory cytokines and mediators, the "cytokine storm". Septic shock is accompanied by a massive increase in mortality of up to 60%.\n\nThis high mortality rate is due to a lack of current treatment options. The early recognition of the disease and its immediate treatment are decisive for successful therapy and the survival of those affected. The most important therapeutic steps, apart from focus control by antibiotics and surgical intervention, are the stabilization of the affected organ systems, in particular the circulatory system and the respiratory system. As an extracorporeal and non-specific procedure for the interruption of the cytokine storm, hemoadsorption by means of CytoSorb adsorbers may be an intervention, which has already demonstrated its basic effectiveness in the treatment of septic and cardiosurgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory septic shock\n* Need for Norepinephrine ≥ 0.25 µg/kg/min\n* IL6 ≥ 1000 ng/l\n* Indication for CRRT\n\nExclusion Criteria:\n\n* Sepsis due to pulmonary or urogenital causes\n* Onset of septic shock longer than 36 hours\n* Liver cirrhosis Child Pugh C\n* "do not resuscitate"-order\n* expected survival \\< 14 days\n* participation in another interventional trial\n* Pregnancy or breastfeeding\n* Lack of consent'}, 'identificationModule': {'nctId': 'NCT04013269', 'acronym': 'ACYSS', 'briefTitle': 'Adjuvant Therapy With CytoSorb in Refractory Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Effect of the CytoSorb Adsorber on Hemodynamic, Immunological and Pharmacokinetic Parameters in Refractory Septic Shock', 'orgStudyIdInfo': {'id': 'ACYSS'}, 'secondaryIdInfos': [{'id': 'DRKS00015483', 'type': 'REGISTRY', 'domain': 'Deutsches Register Klinischer Studien'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CytoSorb-Therapy', 'description': 'Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy in combination with haemadsorption using CytoSorb-Adsorber', 'interventionNames': ['Device: CytoSorb-Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Therapy of septic shock using guideline directed standard of care, including continuous renal replacement therapy'}], 'interventions': [{'name': 'CytoSorb-Therapy', 'type': 'DEVICE', 'description': 'Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy', 'armGroupLabels': ['CytoSorb-Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dominik Jarczak, MD', 'role': 'CONTACT', 'email': 'd.jarczak@uke.de', 'phone': '+49 40 741035315'}, {'name': 'Axel Nierhaus, MD', 'role': 'CONTACT', 'email': 'nierhaus@uke.de', 'phone': '+49 40 741035315'}, {'name': 'Stefan Kluge, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dominik Jarczak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Axel Nierhaus, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christina König, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Dominik Jarczak, MD', 'role': 'CONTACT', 'email': 'd.jarczak@uke.de', 'phone': '+49 40 741035315'}, {'name': 'Axel Nierhaus, MD', 'role': 'CONTACT', 'email': 'nierhaus@uke.de', 'phone': '+49 40 741035315'}], 'overallOfficials': [{'name': 'Stefan Kluge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Hamburg-Eppendorf, Department of Intensive Care Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'CytoSorbents, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}