Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-02 @ 3:47 AM
Study NCT ID:
NCT06069466
Status:
UNKNOWN
Last Update Posted:
2023-10-05
First Post:
2023-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Transcriptome mRNA of blood and BALF'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prognosis of ARDS patients', 'timeFrame': 'from 28d to 1 year', 'description': 'ICU mortality, 28-day mortality, 90-day mortality and 1-year mortality of ARDS patients'}], 'secondaryOutcomes': [{'measure': 'Incidence of ARDS in ICUs', 'timeFrame': '2 years', 'description': 'Incidence of ARDS in ICUs'}, {'measure': 'Length of hospital stay in ARDS patients', 'timeFrame': 'during hospitalization', 'description': 'Length of hospital stay in ARDS patients'}, {'measure': 'VFDs within 28 days', 'timeFrame': '28 days', 'description': 'Mechanical ventilation free days within 28 days'}, {'measure': 'Long-term quality of life and long-term lung function', 'timeFrame': '1 year', 'description': '3month，6month，1year quality of life score and 1year lung function'}, {'measure': 'Rates of mechanical ventilation strategies are consistent with guidelines rates of rates of mechanical ventilation strategies consistent with guidelines', 'timeFrame': 'during hospitalization', 'description': 'consistence of lung protective ventilation strategies（including small tidal volume and limitation of Pplat）'}, {'measure': 'Survival risk factors in hospitalized ARDS patients', 'timeFrame': 'during hospitalization', 'description': 'Survival risk factors in hospitalized ARDS patients'}, {'measure': 'Risk factors for ARDS complications', 'timeFrame': 'during hospitalization', 'description': 'Risk factors for ARDS complications（including AKI and barotrauma）'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARDS; mortality; incidence; prognosis; predictive model; AI'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'This project intends to adopt the multicenter prospective real-world study method to conduct a preliminary study on the incidence, grading, risk factors, respiratory support strategies, in-hospital mortality, 3-month mortality, 6-month mortality, 1-year mortality, quality of life, lung function and limb function recovery, cognitive function, return to work and other conditions of ARDS patients in RICU. By collecting 1,000 patients, a clinical database related to ARDS in China was established to provide essential data and ideas for promoting standardized diagnosis and treatment technology for ARDS patients and further clinical intervention research. At the same time, ARDS biobank was established in China-Japan Hospital and Xiangya Hospital to realize the integration of clinical data and sample resources, and the prediction model of ARDS survival and complications of tuberculosis clinical data and biological samples was established by using big data and AI technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with ARDS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New or worsening respiratory symptoms less than 7 days after the acute blow.\n* CT/X-ray: Double lung infiltration that cannot be fully explained by pleural effusion, lobar/whole atelectasis, and nodule.\n* Respiratory failure that cannot be explained by heart failure or fluid overload\n* After 15min assisted ventilation (PEEP or CPAP ≥ 5cmH2O) or HFNC with flow≥30L/min, PaO2/FiO2≤300mmHg\n* Classification of ARDS: mild (200mmHg \\< PaO2/FIO2 ≤ 300mmHg), moderate (100mmHg \\< PaO2/FIO2 ≤ 200mmHg), and severe (PaO2/FIO2 ≤ 100mmHg) and 4 ancillary variables for severe ARDS\n\nExclusion Criteria:\n\n* younger than 18 years old\n* Patients or family members refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT06069466', 'briefTitle': 'Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': 'Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome in China RICUs-CHARDS II Study', 'orgStudyIdInfo': {'id': '2023-NHLHCRF-YYPP-TS-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARDS patient'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xu Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Respiratory and Critical Care Medicine, China-Japan Friendship Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'Huang Xu', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}