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

Southeast University, China100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Acute Respiratory Distress Syndrome Adrenal Insufficiency

Interventions

hydrocortisoneDRUG

hydrocortisone 100mg q8h

placeboDRUG

normal saline 100ml q8h

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Evidence of clinically definite ARDS confirmed by AECC criteria in 1994

Time frame: within the first 3 days after surgery onset of ARDS

Data from ClinicalTrials.gov

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