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Sponsors and Collaborators: |
Southeast University, China Nanjing Medical University |
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Information provided by: | Southeast University, China |
ClinicalTrials.gov Identifier: | NCT00773058 |
Stress doses of hydrocortisone improve early outcome in patients who is in early stage of ARDS and with relative adrenal insufficiency.
Condition | Intervention | Phase |
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Acute Respiratory Distress Syndrome Adrenal Insufficiency |
Drug: hydrocortisone Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency |
Estimated Enrollment: | 80 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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glucocorticoid: Active Comparator
stress-dose glucocorticoid treatment, compared to placebo group
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Drug: hydrocortisone
hydrocortisone 100mg q8h
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placebo: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Chinese Medical Association ( Dr. QIU Hai-bo ) |
Study ID Numbers: | QHB-YY 2008 |
Study First Received: | October 14, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773058 |
Health Authority: | China: State Food and Drug Administration |
acute respiratory distress syndrome glucocorticoid adrenal insufficiency |
Addison's disease Adrenal Insufficiency Hydrocortisone Autoimmune Diseases Cortisol succinate Respiratory Distress Syndrome, Adult Respiration Disorders Stress Adrenal Gland Diseases Endocrine System Diseases Hypoadrenalism |
Adrenal gland hypofunction Respiratory Tract Diseases Adrenoleukodystrophy Lung Diseases Addison Disease Acute respiratory distress syndrome Hydrocortisone acetate Endocrinopathy Epinephrine X-linked adrenoleukodystrophy |
Anti-Inflammatory Agents Pathologic Processes Disease Immune System Diseases |
Therapeutic Uses Syndrome Pharmacologic Actions |