Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 4:55 AM
Study NCT ID:
NCT03126032
Status:
COMPLETED
Last Update Posted:
2020-04-02
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Glycocalyx Damage in Emergency Room Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of glycocalyx thickness with clinical course.', 'timeFrame': 'At time of presentation in the ER.', 'description': "Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm) will be correlated with patients' clinical course (e.g. with the use of SOFA score - pts.)."}], 'secondaryOutcomes': [{'measure': 'Correlation of glycocalyx thickness with major events.', 'timeFrame': 'Hospital stay, an expected average of 4 weeks.', 'description': 'Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ major events (dialysis, intubation, ICU admission, death)'}, {'measure': 'Correlation of glycocalyx thickness with 90-day mortality.', 'timeFrame': 'Up to 90 days.', 'description': 'Glycocalyx thickness (PBR, in µm) will be correlated with patients΄ 90-day mortality.'}, {'measure': 'Correlation of glycocalyx thickness with subsequent organ failure.', 'timeFrame': 'Hospital stay, an expected average of 4 weeks.', 'description': 'Glycocalyx thickness (PBR, in µm) will be correlated with subsequent organ failure (e.g. kidney, lung, circulation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'SIRS', 'Glycocalyx', 'Glycocheck™-System', 'Infection'], 'conditions': ['Sepsis', 'SIRS']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://microvascular.com/wp-content/uploads/2015/01/MicroVascular-Health-Solutions-Glycocalyx-White-Paper.pdf', 'label': 'Description of GlycoCheck™- System'}]}, 'descriptionModule': {'briefSummary': 'Aim of the study is to evaluate to what extent a glycocalyx damage measured in the ER in patients presenting with sepsis correlates with their clinical course and if it can be used as a clinical stratification tool and mortality predictor.\n\nThe study will focus on the changes of the microcirculation and how they correlate with the macrocirculation, as well as microbiologic parameters. In the study will participate ca. 300 patients with sepsis, as well as 30 patients without sepsis and 30 healthy individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non consecutive patients presenting in the ER of the University Hospital in Muenster, Germany.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with suspected sepsis\n\n* Adult patients presenting to the ER with the clinical suspicion of infection\n* Indication for hospital admission\n\nPatients without sepsis\n\n* Adult patients presenting to the ER with other conditions apart from sepsis/infection.\n\nHealthy individuals\n\n* Adult healthy individuals.\n\nExclusion Criteria (for all groups):\n\n* Underage persons\n* Pregnant women\n* Oral mucosal injuries'}, 'identificationModule': {'nctId': 'NCT03126032', 'acronym': 'EDGE', 'briefTitle': 'Early Detection of Glycocalyx Damage in Emergency Room Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Early Detection of Glycocalyx Damage in Emergency Room Patients', 'orgStudyIdInfo': {'id': 'EDGE 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected sepsis', 'description': 'Patients presenting in the Emergency Room (ER) with the clinical suspicion of infection/sepsis.\n\nEvaluation of the glycocalyx damage with the use of GlycoCheck™-System, as well as blood sample at presentation, day 1 and day 7 of their hospital stay.', 'interventionNames': ['Other: GlycoCheck™-System']}, {'label': 'Non-Sepsis Patients', 'description': 'Patients presenting in the Emergency Room with other conditions apart from infection/sepsis.\n\nEvaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.', 'interventionNames': ['Other: GlycoCheck™-System']}, {'label': 'Healthy Individuals', 'description': 'Evaluation of their sublingual glycocalyx and blood sample for further microbiologic and laboratory analysis at presentation.', 'interventionNames': ['Other: GlycoCheck™-System']}], 'interventions': [{'name': 'GlycoCheck™-System', 'type': 'OTHER', 'description': 'Consecutive, sublingual measurements of endothelial glycocalyx with GlycoCheck™-System will be obtained at presentation, as well as during the inpatient treatment of the patients with suspected sepsis.\n\nBlood sample will be drawn in all groups at time of assessment. Besides that, in patients with suspected sepsis blood samples will be drawn for further microbiologic and laboratory analysis at day 1 and day 7 of their hospital stay.', 'armGroupLabels': ['Healthy Individuals', 'Non-Sepsis Patients', '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 Muenster'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}