Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT03789305
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2018-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'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': 731}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-19', 'studyFirstSubmitDate': '2018-12-25', 'studyFirstSubmitQcDate': '2018-12-25', 'lastUpdatePostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probability not to deteriorate in functional status during the hospital stay', 'timeFrame': 'a median of 30 days', 'description': 'Analysis of the course of functional status measured by the Barthel Score sub-components transfer and ambulation during the hospital stay. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.'}], 'secondaryOutcomes': [{'measure': 'Change in Functional status before hospital admission to ICU discharge', 'timeFrame': 'a median of 20 days', 'description': 'Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to ICU discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.'}, {'measure': 'Change in Functional status before hospital admission to hospital discharge', 'timeFrame': 'a median of 30 days', 'description': 'Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to hospital discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.'}, {'measure': 'ICU length of stay', 'timeFrame': 'a median of 11 days', 'description': 'Duration of stay on intensive care'}, {'measure': 'Hospital length of stay', 'timeFrame': 'a median of 30 days', 'description': 'Duration of stay in the hospital'}, {'measure': 'Rate of discharge disposition to home', 'timeFrame': '1 day', 'description': 'Rate of participants being discharged home after the hospital stay.'}, {'measure': 'ICU mortality', 'timeFrame': 'a median of 11 days', 'description': 'Expired during the intensive care stay'}, {'measure': 'Hospital mortality', 'timeFrame': 'a median of 22 days', 'description': 'Expired during the hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Mobilization', 'Early Rehabilitation', 'Functional Status', 'Functional Outcome', 'Patient Outcome', 'Intensive Care', 'Critical Care Outcomes'], 'conditions': ['Critical Care', 'Rehabilitation', 'Outcome Assessment', 'Critical Illness', 'Frailty', 'Physical and Rehabilitation Medicine', 'Exercise Therapy', 'Intensive Care Unit']}, 'referencesModule': {'references': [{'pmid': '23395245', 'type': 'BACKGROUND', 'citation': 'Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.'}, {'pmid': '28936626', 'type': 'BACKGROUND', 'citation': 'Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.'}, {'pmid': '28289812', 'type': 'BACKGROUND', 'citation': 'Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective analysis of patient registry data of intensive care patients. The aim is to investigate if frailty is a predictor of decline of functional status of critically ill patients during their hospital stay.', 'detailedDescription': 'Elderly critical-ill patients with a high frailty level are becoming increasingly important in the ICU and the health system. Especially, questions about the course of the individual proceeding, withhold of therapy and level of care are controversial among caretakers, as outcome and functional independence remain still unclear in these patients.\n\nThis applies particularly in view of the fact that large studies such as VIP1 showed an inverse association of high frailty classes with short-term survival.\n\nOur main objective in this study was to focus on functional outcome and independency measured by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity and prognosis of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill patients admitted to two intensive care units at a university hospital from the Department of Anesthesiology and Intensive Care in Munich, Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intensive care stay \\> 48 hours\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03789305', 'acronym': 'DEFAULT', 'briefTitle': 'Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes', 'orgStudyIdInfo': {'id': 'DEFAULT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically ill patients', 'description': 'Critically ill patients admitted to intensive care for more than 48 hours'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar, School of Medicine, Technical University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Stefan J Schaller, MD, MHBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.\n\nExamples of reasonable requests are:\n\n* a metaanalysis in the field\n* a research collaboration\n* rerun the analysis Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stefan Schaller', 'investigatorAffiliation': 'Technical University of Munich'}}}}