Effect of Treatment With Stress-Doses Glucocorticoid in Patients With ARDS

This study is not yet open for participant recruitment.

Verified by Southeast University, China, October 2008

Sponsors and Collaborators:	Southeast University, China Nanjing Medical University
Information provided by:	Southeast University, China
ClinicalTrials.gov Identifier:	NCT00773058

Purpose

Stress doses of hydrocortisone improve early outcome in patients who is in early stage of ARDS and with relative adrenal insufficiency.

Condition	Intervention	Phase
Acute Respiratory Distress Syndrome Adrenal Insufficiency	Drug: hydrocortisone Drug: placebo	Phase IV

Genetics Home Reference related topics: X-linked adrenoleukodystrophy

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Epinephrine Epinephrine bitartrate

U.S. FDA Resources

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

Further study details as provided by Southeast University, China:

Primary Outcome Measures:

Evidence of clinically definite ARDS confirmed by AECC criteria in 1994 [ Time Frame: within the first 3 days after surgery onset of ARDS ] [ Designated as safety issue: Yes ]

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
glucocorticoid: Active Comparator stress-dose glucocorticoid treatment, compared to placebo group	Drug: hydrocortisone hydrocortisone 100mg q8h
placebo: Placebo Comparator	Drug: placebo

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994
18 to 85 year old

Exclusion Criteria:

pregnancy or lactation
tumor or other immunologic disease
immunosuppressive drug used
bone marrow or lung transplantation
primary or secondary disease of adrenal gland
hormone used within 3 months
refusing conventional therapy
be in other clinical tests within 30 days

Contacts and Locations

No Contacts or Locations Provided

More Information

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

Keywords provided by Southeast University, China:

acute respiratory distress syndrome
glucocorticoid
adrenal insufficiency

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Disease
Immune System Diseases

Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009