Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-04-23 @ 3:03 PM
Study NCT ID:
NCT02706457
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2016-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Intensive Care Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000657744', 'term': 'postintensive care syndrome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 849}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2016-03-07', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Barthel Index', 'timeFrame': 'from januari 2012 until decembre 2014', 'description': 'barthel index is analyzed over the years 2012 - 2014'}], 'secondaryOutcomes': [{'measure': 'Relation between Barthel Index and length of stay in ICU', 'timeFrame': 'from januari 2012 until decembre 2014'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intensive care', 'functionality'], 'conditions': ['Post Intensive Care Syndrome', 'Barthel Index']}, 'descriptionModule': {'briefSummary': 'Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.', 'detailedDescription': 'idem'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated in Intensive Care for minimal 48 hours, during the years 2012 - 2014', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* length of stay longer than 48 hours\n\nExclusion Criteria:\n\n* no exclusion criteria if inclusion is correct'}, 'identificationModule': {'nctId': 'NCT02706457', 'briefTitle': 'Post Intensive Care Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Frisius Medisch Centrum'}, 'officialTitle': 'Do Improvements in Functionality on the ICU Give a Reduction of Post Intensive Care Syndrome', 'orgStudyIdInfo': {'id': 'nWMO 143'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cohort 2012 - 2014', 'description': 'all patients admitted for \\> 48 hours on the Intensive Care Unit in 2012, 2013 and 2014', 'interventionNames': ['Other: Barthel index for functionality']}], 'interventions': [{'name': 'Barthel index for functionality', 'type': 'OTHER', 'description': 'The Barthel Index for functionality is done standard in all patients after intensive care admission', 'armGroupLabels': ['cohort 2012 - 2014']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8904 BR', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medical Center Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}], 'overallOfficials': [{'name': 'Matty Koopmans, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MCL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frisius Medisch Centrum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Matty Koopmans', 'investigatorAffiliation': 'Frisius Medisch Centrum'}}}}