Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02849756
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2016-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Future of the Older Patients After Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007362', 'term': 'Intensive Care Units'}], 'ancestors': [{'id': 'D006757', 'term': 'Hospital Units'}, {'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ALD score', 'timeFrame': 'Six month', 'description': 'Geriatric score of autonomy'}], 'secondaryOutcomes': [{'measure': 'survival', 'timeFrame': 'Six month', 'description': 'survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intensive care', 'elderly', 'autonomy', 'Future', 'older patients', 'intensive care unit'], 'conditions': ['Intensive Care Unit Syndrome']}, 'referencesModule': {'references': [{'pmid': '21263318', 'type': 'BACKGROUND', 'citation': 'Khouli H, Astua A, Dombrowski W, Ahmad F, Homel P, Shapiro J, Singh J, Nallamothu R, Mahbub H, Eden E, Delfiner J. Changes in health-related quality of life and factors predicting long-term outcomes in older adults admitted to intensive care units. Crit Care Med. 2011 Apr;39(4):731-7. doi: 10.1097/CCM.0b013e318208edf8.'}, {'pmid': '22107108', 'type': 'BACKGROUND', 'citation': 'Lewis-Newby M, Curtis JR, Martin DP, Engelberg RA. Measuring family satisfaction with care and quality of dying in the intensive care unit: does patient age matter? J Palliat Med. 2011 Dec;14(12):1284-90. doi: 10.1089/jpm.2011.0138. Epub 2011 Nov 22.'}, {'pmid': '24132383', 'type': 'BACKGROUND', 'citation': 'Biston P, Aldecoa C, Devriendt J, Madl C, Chochrad D, Vincent JL, De Backer D. Outcome of elderly patients with circulatory failure. Intensive Care Med. 2014 Jan;40(1):50-6. doi: 10.1007/s00134-013-3121-7. Epub 2013 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'Estimate the future six months after the admission in an intensive care unit of the patients of 85 and more years old in terms of autonomy.', 'detailedDescription': 'The diverse studies published on the future of the elderly hospitalized in resuscitation place the limit very low, between 65 and 80 years. The feeling of a very bad forecast at these extreme ages pulls nevertheless a filter in the admission in ICU which has this day no scientific justification. The knowledge of the evolution after the hospitalization of these older patients can help to make certain decisions concerning as well the admission of these patients in ICU as the realization of invasive treatments.\n\nAfter informal interrogation of numerous intensivists, it seems to take shape a bar around 85 years beyond which the forecast would be worse without more proof what consolidated the choice of this limit.\n\nThe reserved scores were already used in similar studies (simplified ALD).\n\nPrimary purpose :\n\n* Describe the survival and the evolution of the quality of life after a stay in resuscitation for very old patients.\n* The quality of life will be studied through a score of autonomy: the simplified ALD score.\n\nThe population will be described in general then by age bracket (more or less of 90 years old), according to the length of stay in ICU, the heavy treatments (artificial ventilation, renal replacement therapy) practiced, the initial gravity (score IGS 2). The impact of possible decisions of Limitation or Stop of Therapeutic Activates will also be taken into account.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '85 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 85 years hospitalized in intensive care unit will be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 85 years old staying in intensive car units\n\nExclusion Criteria:\n\n* Knaus D\n* No possibly of call (phone) 6 months after ICU admission\n* Patients who do not speak French\n* Patients do not accept the participation'}, 'identificationModule': {'nctId': 'NCT02849756', 'acronym': 'DAAR', 'briefTitle': 'Future of the Older Patients After Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'Future of the Older Patients After Intensive Care Unit', 'orgStudyIdInfo': {'id': 'CHRD0514'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'older in intensive care unit', 'description': 'older (age superior at 85 years) hospitalized in intensive care unit. A follow-up until 6 months after hospitalization will determine the evolution of the quality of life and others secondary outcomes.', 'interventionNames': ['Other: older in intensive care unit']}], 'interventions': [{'name': 'older in intensive care unit', 'type': 'OTHER', 'description': 'It is an observational study with no intervention.', 'armGroupLabels': ['older in intensive care unit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95303', 'city': 'Pontoise', 'state': "Val d'Oise", 'country': 'France', 'facility': 'René-Dubos Hospital', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}], 'overallOfficials': [{'name': 'Philippe Dr MICHEL, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'René-Dubos Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}