Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03847493
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2019-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of glycocalyx thickness regarding clinical course.', 'timeFrame': 'Hospital stay, an expected time of 4 weeks.', 'description': 'Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm). Clinical course will be estimated with the use of e.g. Sequential Organ Failure Assessment (SOFA) score (in points).'}, {'measure': 'Predictive value of glycocalyx thickness regarding mortality.', 'timeFrame': 'Hospital stay, an expected time of 4 weeks.', 'description': 'Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm).'}], 'secondaryOutcomes': [{'measure': 'Correlation of glycocalyx thickness with disease severity.', 'timeFrame': 'Hospital stay, an expected time of 4 weeks.', 'description': 'Glycocalyx thickness will be measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in μm). Disease severity will be assessed with ICU scores (e.g. SOFA Score - pts)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perfused boundary region', 'PBR', 'Sepsis', 'endothelial glycocalyx', 'ICU'], 'conditions': ['Sepsis', 'Septic Shock', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Therefore, the enrollment of ca 100 ICU patients is planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock.\n\nExclusion Criteria:\n\n* Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.'}, 'identificationModule': {'nctId': 'NCT03847493', 'acronym': 'ASGARD', 'briefTitle': 'Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death - the ASGARD Study', 'orgStudyIdInfo': {'id': 'ASGARD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected sepsis', 'description': 'Patients admitted in the ICU with the clinical suspicion of infection/sepsis.', 'interventionNames': ['Other: Endothelial Glycocalyx']}, {'label': 'Non-sepsis Patients (control group)', 'description': 'Patients admitted in the ICU with other conditions apart from infection/sepsis.', 'interventionNames': ['Other: Endothelial Glycocalyx']}], 'interventions': [{'name': 'Endothelial Glycocalyx', 'type': 'OTHER', 'description': 'Non-invasive assessment of endothelial glycocalyx dimensions.', 'armGroupLabels': ['Non-sepsis Patients (control group)', 'Patients with suspected sepsis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitiy Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Philipp Kümpers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}