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

Phase 4

• Conditions: Acute Respiratory Distress Syndrome; Adrenal Insufficiency
• Interventions: Drug: placebo; Drug: hydrocortisone

• Registration Number: NCT00773058
• Lead Sponsor: Southeast University, China

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Study Start: 2008-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18
• Primary Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo + RAI	placebo	no glucocorticoid But ATCH test hints RAI
placebo	placebo	no glucocorticoid But ATCH test does not hint RAI
glucocorticoid+RAI	hydrocortisone	stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI
glucocorticoid	hydrocortisone	stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI

Primary Outcome Measures

Name	Time	Method
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994	within the first 3 days after surgery onset of ARDS