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

Southeast University, China

Status and phase: Unknown; Phase 4

Conditions: Adrenal Insufficiency; Acute Respiratory Distress Syndrome

Treatments: Drug: placebo; Drug: hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT00773058

QHB-YY 2008

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups, including a placebo group

glucocorticoid+RAI

Active Comparator group

Description:

stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI

Treatment:

Drug: hydrocortisone

placebo + RAI

Placebo Comparator group

Description:

no glucocorticoid But ATCH test hints RAI

Treatment:

Drug: placebo

glucocorticoid

Active Comparator group

Description:

stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI

Treatment:

Drug: hydrocortisone

placebo

Placebo Comparator group

Description:

no glucocorticoid But ATCH test does not hint RAI

Treatment:

Drug: placebo