Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-06-06 @ 11:02 PM
Study NCT ID:
NCT03216850
Status:
COMPLETED
Last Update Posted:
2019-11-27
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Lipid Emulsion on GCX in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astapenko.d@seznam.cz', 'phone': '+420495833218', 'title': 'Dr. David Astapenko', 'organization': 'University Hospital Hradec Kralove'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Measurement of the endothelial glycocalyx thickness is harmless and partially non-invasive. The study was observational and did not aim at collecting the data about adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients in ICU Requiring Parenteral Nutrition', 'description': 'Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endothelial Glycocalyx Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients in ICU Requiring Parenteral Nutrition', 'description': 'Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '2.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'One week within the ICU care', 'description': 'Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients in ICU Requiring Parenteral Nutrition', 'description': 'Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '6 patients did not complete the study because of the pre-analytical error.', 'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Pre-analytical error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients in ICU Requiring Parenteral Nutrition', 'description': 'Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PBR value', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.10', 'groupId': 'BG000', 'lowerLimit': '1.97', 'upperLimit': '2.33'}]}]}], 'paramType': 'MEDIAN', 'description': 'Perfused Boundary Region (PBR) is an indirect assessment of the endothelial glycocalyx thickness in sublingual microcirculation.', 'unitOfMeasure': 'micrometer', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-07', 'size': 74131, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-08T04:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-08', 'studyFirstSubmitDate': '2017-07-11', 'resultsFirstSubmitDate': '2019-03-25', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-08', 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Glycocalyx Thickness', 'timeFrame': 'One week within the ICU care', 'description': 'Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.\n\nThe aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.\n\nMonitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who meet the inclusion criteria admitted to the ICU.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients in ICU\n* indication for lipid administration as a part of TPN\n\nExclusion Criteria:\n\n* shock or clinical/laboratory signs of tissue hypoperfusion\n* previous lipid infusions (within 3 months before entering study)\n* hyperlipidaemia\n* hyperglycaemia (over 10 mmol/l)\n* current or previous (within 72 hours before entering the study) use of propofol\n* pancreatitis\n* severe liver failure\n* current use of statins'}, 'identificationModule': {'nctId': 'NCT03216850', 'briefTitle': 'Evaluation of Lipid Emulsion on GCX in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX', 'orgStudyIdInfo': {'id': 'AZVCR 9307_5/a'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients in ICU requiring parenteral nutrition', 'interventionNames': ['Device: Sublingual microcirculation assessment']}], 'interventions': [{'name': 'Sublingual microcirculation assessment', 'type': 'DEVICE', 'description': 'Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.', 'armGroupLabels': ['Patients in ICU requiring parenteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'state': 'Třebeš', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}], 'overallOfficials': [{'name': 'Vladimir Cerny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Hradec Kralove'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Vladimir Cerny', 'investigatorAffiliation': 'University Hospital Hradec Kralove'}}}}