Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 9:59 PM
Study NCT ID:
NCT03654456
Status:
UNKNOWN
Last Update Posted:
2019-05-16
First Post:
2018-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Sleep Apnea on Sepsis Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2018-07-24', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'up to 40 days', 'description': 'percentage of sepsis patients died of sepsis'}], 'secondaryOutcomes': [{'measure': 'Survival time', 'timeFrame': 'up to 40 days', 'description': 'Survival time is defined as the length from the date when sepsis is diagnosed to date of discharge or death'}, {'measure': 'Mortality', 'timeFrame': '7-day', 'description': 'percentage of sepsis patients died of sepsis'}, {'measure': 'Mortality', 'timeFrame': '28-day', 'description': 'percentage of sepsis patients died of sepsis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea', 'sepsis', 'outcome', 'prognosis', 'sleep-disordered breathing'], 'conditions': ['Sleep Apnea Syndromes', 'Sepsis', 'Mortality']}, 'referencesModule': {'references': [{'pmid': '12682500', 'type': 'BACKGROUND', 'citation': 'Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.'}, {'pmid': '24117403', 'type': 'RESULT', 'citation': 'Huang CY, Chen YT, Wu LA, Liu CJ, Chang SC, Perng DW, Chen YM, Chen TJ, Lee YC, Chou KT. Sleep apnoea patients have higher mortality when confronting sepsis. Eur J Clin Invest. 2014 Jan;44(1):38-45. doi: 10.1111/eci.12187. Epub 2013 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'By clinical record review, this retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.', 'detailedDescription': 'This retrospective study aims to compare the mortality of sepsis patients with versus without obstructive sleep apnea (OSA). Patients with a diagnosis of sepsis, who had received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography and details related to sepsis (source of infection, number of organ dysfunction at initial diagnosis of sepsis and survival time) will be collected. The start of the survival time (follow-up time) is the date when sepsis is diagnosed. The end of the survival time (follow-up time) is the date of death or end of hospitalization (date of discharge). Survival analyses will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sepsis Patients who had received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017 will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who received received a polysomnography at Taipei Veterans General Hospital during Jan. 1, 2001 to May 31, 2017\n2. Patients who were admitted with a diagnosis of sepsis after the polysomnography\n3. The diagnosis of sepsis fulfilling the clinical criteria\n\nExclusion Criteria:\n\n1. Younger than 20 years\n2. Not compatible with a definition of sepsis\n3. subjects with incomplete data'}, 'identificationModule': {'nctId': 'NCT03654456', 'briefTitle': 'Impact of Sleep Apnea on Sepsis Mortality', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'The Impact of Sleep Apnea on the Mortality of Sepsis - A Retrospective Study', 'orgStudyIdInfo': {'id': '2018-06-019AC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sepsis patients with OSA', 'description': 'Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index at least 5/hr with compatible symptoms', 'interventionNames': ['Biological: OSA']}, {'label': 'Sepsis patients without OSA', 'description': 'Sepsis patients who received a prior polysomnography showing an apnea-hypopnea index less than 5/hr'}], 'interventions': [{'name': 'OSA', 'type': 'BIOLOGICAL', 'description': 'The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.', 'armGroupLabels': ['Sepsis patients with OSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kun-Ta Chou, M.D', 'role': 'CONTACT', 'email': 'ale1371@yahoo.com.tw', 'phone': '922407055'}, {'name': 'Kun-Ta Chou, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Kun-Ta Chou, M.D', 'role': 'CONTACT', 'email': 'ale1371@yahoo.com.tw', 'phone': '886922407055'}], 'overallOfficials': [{'name': 'Kun-Ta Chou, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Veterans General Hospital, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}