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

NCT ID: NCT00773058

Last Updated: 2009-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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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

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Conditions

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Acute Respiratory Distress Syndrome Adrenal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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glucocorticoid+RAI

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

Group Type ACTIVE_COMPARATOR

hydrocortisone

Intervention Type DRUG

hydrocortisone 100mg q8h

placebo + RAI

no glucocorticoid But ATCH test hints RAI

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

normal saline 100ml q8h

glucocorticoid

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

Group Type ACTIVE_COMPARATOR

hydrocortisone

Intervention Type DRUG

hydrocortisone 100mg q8h

placebo

no glucocorticoid But ATCH test does not hint RAI

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

normal saline 100ml q8h

Interventions

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hydrocortisone

hydrocortisone 100mg q8h

Intervention Type DRUG

placebo

normal saline 100ml q8h

Intervention Type DRUG

Other Intervention Names

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glucocorticoid cortical hormone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role collaborator

Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Chinese Medical Association

Other Identifiers

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QHB-YY 2008

Identifier Type: -

Identifier Source: org_study_id

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