Overview

This trial is active, not recruiting.

Conditions acute respiratory distress syndrome, adrenal insufficiency
Treatments hydrocortisone, placebo
Phase phase 4
Sponsor Southeast University, China
Collaborator Nanjing Medical University
Start date December 2008
End date April 2009
Trial size 100 participants
Trial identifier NCT00773058, QHB-YY 2008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI
hydrocortisone glucocorticoid
hydrocortisone 100mg q8h
(Placebo Comparator)
no glucocorticoid But ATCH test hints RAI
placebo
normal saline 100ml q8h
(Active Comparator)
stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI
hydrocortisone glucocorticoid
hydrocortisone 100mg q8h
(Placebo Comparator)
no glucocorticoid But ATCH test does not hint RAI
placebo
normal saline 100ml q8h

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Southeast University, China.