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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Southeast University, China. Recruitment status was Active, not recruiting

First Received on October 14, 2008. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency

Resource links provided by NLM:

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
Active Comparator: glucocorticoid+RAI stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI	Drug: hydrocortisone hydrocortisone 100mg q8h Other Names: glucocorticoid cortical hormone
Placebo Comparator: placebo + RAI no glucocorticoid But ATCH test hints RAI	Drug: placebo normal saline 100ml q8h
Active Comparator: glucocorticoid stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI	Drug: hydrocortisone hydrocortisone 100mg q8h Other Names: glucocorticoid cortical hormone
Placebo Comparator: placebo 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:	Dr. QIU Hai-bo, Chinese Medical Association
ClinicalTrials.gov Identifier:	NCT00773058 History of Changes
Other Study ID Numbers:	QHB-YY 2008
Study First Received:	October 14, 2008
Last Updated:	February 17, 2009
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:

Adrenal Insufficiency
Addison Disease
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases

Infant, Newborn, Diseases
Lung Injury
Glucocorticoids
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012