Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-05 @ 12:47 PM
Study NCT ID:
NCT04259567
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2020-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in the index of cerebrovascular autoregulation (Mx) between both groups', 'timeFrame': 'days 1 to 4 after diagnosis of septic shock', 'description': 'Integrity of the cerebrovascular autoregulation will be measured using the index of cerebrovascular autoregulation Mx (moving correlation index). Outcome is the difference of the mean Mx between both groups and, therefore, the difference of integrity of the cerbrovascular autoregulation. A difference of 0.2 in Mx was set as clinically relevant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebrovascular Autoregulation', 'Septic Shock', 'Cytokine'], 'conditions': ['Septic Shock']}, 'descriptionModule': {'briefSummary': 'The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* septic shock\n* acute renal failure with need for renal replacement therapy\n\nExclusion Criteria:\n\n* pregnancy\n* nursing\n* impossibility to do transcranial Doppler ultrasound'}, 'identificationModule': {'nctId': 'NCT04259567', 'acronym': 'SepsAR3', 'briefTitle': 'Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren', 'orgStudyIdInfo': {'id': 'V1.0_2019_06_28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Filter', 'description': 'Patients with CytoSorb absorber', 'interventionNames': ['Device: Cytokine absorption']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients without CytoSorb absorber'}], 'interventions': [{'name': 'Cytokine absorption', 'type': 'DEVICE', 'description': 'Use of CytoSorb absorber', 'armGroupLabels': ['Filter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Patrick Schramm, MD', 'role': 'CONTACT', 'email': 'schrammp@uni-mainz.de', 'phone': '00496131176755'}, {'name': 'Patrick Schramm, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center of the Johannes Gutenberg-Univerity', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy intensive care unit, Principal investigator, medical doctor', 'investigatorFullName': 'Patrick Schramm', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}