Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-04-07 @ 1:40 PM
Study NCT ID:
NCT00773058
Status:
UNKNOWN
Last Update Posted:
2009-02-18
First Post:
2008-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-10-03', 'releaseDate': '2011-08-29'}], 'estimatedResultsFirstSubmitDate': '2011-08-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D005938', 'term': 'Glucocorticoids'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2008-10-14', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of clinically definite ARDS confirmed by AECC criteria in 1994', 'timeFrame': 'within the first 3 days after surgery onset of ARDS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute respiratory distress syndrome', 'glucocorticoid', 'adrenal insufficiency'], 'conditions': ['Acute Respiratory Distress Syndrome', 'Adrenal Insufficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if stress doses of hydrocortisone improve early outcome in patients who are in early stage of ARDS and with relative adrenal insufficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994\n* 18 to 85 year old\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* tumor or other immunologic disease\n* immunosuppressive drug used\n* bone marrow or lung transplantation\n* primary or secondary disease of adrenal gland\n* hormone used within 3 months\n* refusing conventional therapy\n* be in other clinical tests within 30 days'}, 'identificationModule': {'nctId': 'NCT00773058', 'briefTitle': 'Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency', 'orgStudyIdInfo': {'id': 'QHB-YY 2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'glucocorticoid+RAI', 'description': 'stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI', 'interventionNames': ['Drug: hydrocortisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + RAI', 'description': 'no glucocorticoid But ATCH test hints RAI', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'glucocorticoid', 'description': 'stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI', 'interventionNames': ['Drug: hydrocortisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'no glucocorticoid But ATCH test does not hint RAI', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'hydrocortisone', 'type': 'DRUG', 'otherNames': ['glucocorticoid', 'cortical hormone'], 'description': 'hydrocortisone 100mg q8h', 'armGroupLabels': ['glucocorticoid', 'glucocorticoid+RAI']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'normal saline 100ml q8h', 'armGroupLabels': ['placebo', 'placebo + RAI']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. QIU Hai-bo', 'oldOrganization': 'Chinese Medical Association'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-08-29', 'type': 'RELEASE'}, {'date': '2011-10-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'YYang, prof., Southeast University, China'}}}}