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NCT00773058 Clinical Trial

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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00773058
Other study ID # QHB-YY 2008
Secondary ID
Status Unknown status
Phase Phase 4
First received October 14, 2008
Last updated February 17, 2009
Start date December 2008

Study information
Verified date January 2009
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 100
Est. completion date
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• hydrocortisone
hydrocortisone 100mg q8h
• placebo
normal saline 100ml q8h

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Southeast University, China Nanjing Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence of clinically definite ARDS confirmed by AECC criteria in 1994 within the first 3 days after surgery onset of ARDS
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