Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)

This study is ongoing, but not recruiting participants.

First Received: October 14, 2008 Last Updated: February 17, 2009 History of Changes

Sponsor:	Southeast University, China
Collaborator:	Nanjing Medical University
Information provided by:	Southeast University, China
ClinicalTrials.gov Identifier:	NCT00773058

Purpose

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.

Condition	Intervention	Phase
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked adrenoleukodystrophy

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

U.S. FDA Resources

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:	100
Study Start Date:	December 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
glucocorticoid+RAI: Active Comparator stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI	Drug: hydrocortisone hydrocortisone 100mg q8h
placebo + RAI: Placebo Comparator no glucocorticoid But ATCH test hints RAI	Drug: placebo normal saline 100ml q8h
glucocorticoid: Active Comparator stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI	Drug: hydrocortisone hydrocortisone 100mg q8h
placebo: Placebo Comparator no glucocorticoid But ATCH test does not hint RAI	Drug: placebo normal saline 100ml q8h

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

No publications provided

Responsible Party:	Chinese Medical Association ( Dr. QIU Hai-bo )
Study ID Numbers:	QHB-YY 2008
Study First Received:	October 14, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00773058 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Southeast University, China:

acute respiratory distress syndrome
glucocorticoid
adrenal insufficiency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Adrenal Insufficiency
Hydrocortisone
Autoimmune Diseases
Disease
Cortisol succinate
Immune System Diseases
Physiological Effects of Drugs
Respiratory Distress Syndrome, Adult
Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenal Gland Diseases

Endocrine System Diseases
Hormones
Glucocorticoids
Pharmacologic Actions
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Syndrome
Lung Diseases
Addison Disease
Hydrocortisone acetate

ClinicalTrials.gov processed this record on February 08, 2010