Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-01 @ 12:55 PM
Study NCT ID:
NCT04169204
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2019-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Very Old Intensive Care Patients - Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bedside measurement of sublingual microcirculation', 'timeFrame': 'admission of the intensive care unit', 'description': 'measurement of sublingual microcirculation by using MicroScan® microscope'}, {'measure': 'bedside measurement of sublingual microcirculation', 'timeFrame': 'after 24 hours', 'description': 'measurement of sublingual microcirculation by using MicroScan® microscope'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'after 30 days, 6 months and 12 months'}, {'measure': 'Length of stay at ICU', 'timeFrame': 'tdays from admission of the intensive care unit until discharge'}, {'measure': 'Use of Vasopressors and fluids', 'timeFrame': 'days from admission of the intensive care unit until discharge'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microcirculation', 'Intensive Care', 'Critical care', 'shock', 'Very Old Intensive Care Patients', 'risk stratification', 'SDF-measurement'], 'conditions': ['Microcirculation', 'Intensive Care', 'Very Old Intensive Care Patients']}, 'referencesModule': {'references': [{'pmid': '39463395', 'type': 'DERIVED', 'citation': 'Bruno RR, Schemmelmann M, Hornemann J, Moecke HME, Demirtas F, Palici L, Marinova R, Kanschik D, Binnebossel S, Spomer A, Guidet B, Leaver S, Flaatten H, Szczeklik W, Mikiewicz M, De Lange DW, Quenard S, Beil M, Kelm M, Jung C. Sublingual microcirculatory assessment on admission independently predicts the outcome of old intensive care patients suffering from shock. Sci Rep. 2024 Oct 27;14(1):25668. doi: 10.1038/s41598-024-77357-y.'}]}, 'descriptionModule': {'briefSummary': 'Shock is a frequent, etiologically heterogeneous and often lethal clinical condition of intensive care medicine. This is particularly true for very old intensive care patients (VIPs), who are among the fastest-growing subgroups of all intensive care unit (ICU) patients and who suffer from a significantly impaired outcome. In addition to the treatment of the causes of shock, current therapeutic approaches focus on the stabilization of vital parameters, which in general all reflect macrocirculatory measured values such as blood pressure. In contrast, a disturbance of the microcirculation (blood circulation of the smaller blood vessels \\<100 µm) is only poorly measurable and delayed. The last generation of AVA-Software (MicroVisionMedical) will calculate different parameters about the capillary densitiv and perfusion in a user-independent way. VIPPER investigates whether a non-invasive measurement of microcirculation using the sublingual mucosa in very old intensive care patients in shock leads to faster recognition and specific treatment of organ dysfunctions. Secondly, this study checks whether this measurement predicts outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very Old Intensive Care Patients with shock', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 80 years\n* Acute ICU admission\n* Shock at the time point of admission to the ICU or in the first 3 hours defined as Lactate ≥ 2 mmol/l AND need for vasoactive substances to maintain a MAP ≥ 65 mmHg in the presence of adequate volume status\n\nExclusion Criteria:\n\n* \\< 80 years\n* Inaccessibility for sublingual measurement\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT04169204', 'acronym': 'VIPPER', 'briefTitle': 'Very Old Intensive Care Patients - Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Very Old Intensive Care Patients - Perfusion (VIPPER)', 'orgStudyIdInfo': {'id': '19-021'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Measurement of microcirculation', 'type': 'DIAGNOSTIC_TEST', 'description': 'As a simple clinical test, every patient will receive the assessment capillary refill time and mottling-score. Additionally, repetitive measurements of lactate will be done. The SDF-camera (MicroVision Medical®, Amsterdam, Netherlands) will measure sublingual microcirculation at different time points (Admission and 24h).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonary Disease and Vascular Medicine', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}