Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04644302
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2020-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in Proportion of Perfused Vessels (PPV) parameter', 'timeFrame': '1st, 2nd and 3rd day', 'description': 'PPV describes microcirculation dysfunction'}, {'measure': 'change in Syndecan-1 serum concentration', 'timeFrame': '1st, 2nd and 3rd day', 'description': 'Syndecan-1 is a marker of endothelial glycocalyx'}], 'secondaryOutcomes': [{'measure': 'change in albuminuria', 'timeFrame': '1st, 2nd and 3rd day', 'description': 'albuminuria is a marker of glomerular endothelial cells dysfunction'}, {'measure': 'mortality in 28 days', 'timeFrame': '30 days', 'description': 'mortality in 28 days from ICU admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microcirculation', 'endothelial glycocalyx', 'COVID-19'], 'conditions': ['Viral Pneumonia', 'Sepsis']}, 'descriptionModule': {'briefSummary': 'This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course', 'detailedDescription': 'This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to the ICU with signs of circulatory instability with any method of organ support. Patients expected to have a particular method of organ support for at least 3 days.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* ICU admission due to sepsis with organ failure\n* need for organ support therapy (mechanical ventilation, CRRT, ECMO)\n* clinical and/or laboratory signs of circulatory instability\n\nExclusion Criteria:\n\n* family withdrawal/disagreement\n* death within three days from ICU admission'}, 'identificationModule': {'nctId': 'NCT04644302', 'briefTitle': 'Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study', 'orgStudyIdInfo': {'id': 'FNHK_IGS_8144'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-COVID sepsis', 'description': 'Patients admitted to ICU with sepsis of non-COVID origin', 'interventionNames': ['Diagnostic Test: microcirculation recording']}, {'label': 'COVID sepsis', 'description': 'Patients admitted to ICU with sepsis of COVID origin', 'interventionNames': ['Diagnostic Test: microcirculation recording']}], 'interventions': [{'name': 'microcirculation recording', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['biochemical markeres investigation'], 'description': 'non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws', 'armGroupLabels': ['COVID sepsis', 'non-COVID sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'state': 'Třebeš', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Vladimir Cerny', 'investigatorAffiliation': 'University Hospital Hradec Kralove'}}}}