Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02212093
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bacteriology tests'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2014-08-07', 'studyFirstSubmitQcDate': '2014-08-07', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5 years mortality', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'cause of death after discharge from the hospital', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumonia, mechanical ventilation, ICU, mortality'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Severe pneumonia has a high in-hospital mortality. There are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. In this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an ICU. We will also investigate the cause of death after discharge from the hospital.', 'detailedDescription': "Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality (16-46%). There are few studies which investigate the long-term mortality (\\> 1year) in patients after discharge from the hospital. There seems to be a higher mortality in this group compared to the general population. The cause(s) of this higher long-term mortality is unclear and few studies have investigated this problem.\n\nWe are going to investigate the 5 years mortality rate in this population of patients. We are also going to investigate the cause of death in the patients who are discharged from the hospital alive.\n\nInclusion criteria: Patients \\> 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.\n\nThe datas are collected from the patients' journals and the local ICU register. Collecting data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia (bacteriology).\n\nTime of death after discharge is collected from Norwegian National Registry. Cause of death after discharge is collected from Norwegian Institute of Public Health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The same as the inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrived the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.\n\nExclusion Criteria:\n\n* Patients \\< 18 years. Patients with need for mechanical ventilation \\< 24 hours'}, 'identificationModule': {'nctId': 'NCT02212093', 'acronym': 'pneumonia', 'briefTitle': '5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Cause-specific 5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study', 'orgStudyIdInfo': {'id': '2013/2338'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pneumonia and mechanical ventilation', 'description': 'The data are collected retrospectively from this one group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Nordbyhagen', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Akershus University Hospital'}], 'overallOfficials': [{'name': 'Vegard Dahl, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vegard Dahl', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}