Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-19 @ 7:03 PM
Study NCT ID:
NCT03807232
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors, Demographics and Mortality for ARDS in Burn Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D002056', 'term': 'Burns'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-15', 'studyFirstSubmitDate': '2018-09-13', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post-burn ARDS', 'timeFrame': '6 years', 'description': 'Number of patients who developed post-burn ARDS among 400 Patients admitted to Burns Intensive Care Unit of University Hospital Zurich'}, {'measure': 'Clinical course of post-burn-ARDS', 'timeFrame': '6 years', 'description': 'various clinical parameters related to the Outcome of post-burn-ARDS'}, {'measure': 'predictors of post-burn ARDS', 'timeFrame': '6 years', 'description': 'To identify relevant predictors of post-burn ARDS, including the development of a prognostic score'}], 'secondaryOutcomes': [{'measure': 'to examine outcome parameter mortality', 'timeFrame': '6 years', 'description': 'A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich'}, {'measure': 'to examine outcome parameter hospital stay', 'timeFrame': '6 years', 'description': 'A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS, Human', 'Burns', 'Lung Diseases', 'Risk Factors', 'Retrospective Studies', 'Decision Support Techniques'], 'conditions': ['ARDS, Human', 'Burns', 'Lung Diseases']}, 'descriptionModule': {'briefSummary': 'This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS burn score), which was derived from these independent predictors. The newly developed score may be helpful for the development of specific treatment strategies.', 'detailedDescription': 'Rationale:\n\nAcute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a severe complication associated with a mortality of up to 44%. To date, only few studies have been published on the clinical course and predictive factors of pbARDS.\n\nObjectives:\n\nTo characterize the clinical course of pbARDS, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days.\n\nMethods:\n\nA retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression was used to determine independent risk factors for pbARDS. A prognostic score was developed, which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic (ROC) curves.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nall patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.\n\nExclusion Criteria:\n\nExclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.'}, 'identificationModule': {'nctId': 'NCT03807232', 'briefTitle': 'Predictive Factors, Demographics and Mortality for ARDS in Burn Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Predictive Factors, Demographics and Mortality for ARDS in Burn Patients', 'orgStudyIdInfo': {'id': 'ARDS in Burn Patients USZ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pbARDS', 'description': 'Burn patients who developed post-burn ARDS'}, {'label': 'No pbARDS', 'description': 'Burn patients without development of post-burn ARDS'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pietro Giovanoli, Prof. Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsspital Zürich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}