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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00773058
Recruitment Status : Unknown
Verified January 2009 by Southeast University, China.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2008
Last Update Posted : February 18, 2009
Sponsor:
Collaborator:
Nanjing Medical University
Information provided by:
Southeast University, China

Tracking Information
First Submitted Date  ICMJE October 14, 2008
First Posted Date  ICMJE October 16, 2008
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE December 2008
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2008)
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994 [ Time Frame: within the first 3 days after surgery onset of ARDS ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)
Official Title  ICMJE Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Adrenal Insufficiency
Intervention  ICMJE
  • Drug: hydrocortisone
    hydrocortisone 100mg q8h
    Other Names:
    • glucocorticoid
    • cortical hormone
  • Drug: placebo
    normal saline 100ml q8h
Study Arms  ICMJE
  • Active Comparator: glucocorticoid+RAI
    stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI
    Intervention: Drug: hydrocortisone
  • Placebo Comparator: placebo + RAI
    no glucocorticoid But ATCH test hints RAI
    Intervention: Drug: placebo
  • Active Comparator: glucocorticoid
    stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI
    Intervention: Drug: hydrocortisone
  • Placebo Comparator: placebo
    no glucocorticoid But ATCH test does not hint RAI
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
100
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2008)
80
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00773058
Other Study ID Numbers  ICMJE QHB-YY 2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. QIU Hai-bo, Chinese Medical Association
Study Sponsor  ICMJE Southeast University, China
Collaborators  ICMJE Nanjing Medical University
Investigators  ICMJE Not Provided
PRS Account Southeast University, China
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP