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

February 17, 2009 updated by: Southeast University, China

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: glucocorticoid+RAI
stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI
Drug: hydrocortisone
hydrocortisone 100mg q8h
Other Names:
  • glucocorticoid
  • cortical hormone
Placebo Comparator: placebo + RAI
no glucocorticoid But ATCH test hints RAI
Drug: placebo
normal saline 100ml q8h
Active Comparator: glucocorticoid
stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI
Drug: hydrocortisone
hydrocortisone 100mg q8h
Other Names:
  • glucocorticoid
  • cortical hormone
Placebo Comparator: placebo
no glucocorticoid But ATCH test does not hint RAI
Drug: placebo
normal saline 100ml q8h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994
Time Frame: within the first 3 days after surgery onset of ARDS
within the first 3 days after surgery onset of ARDS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Collaborators

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

April 1, 2009

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QHB-YY 2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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