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

• ClinicalTrials.gov Identifier: NCT00773058
• Recruitment Status: Unknown
• First Posted: October 16, 2008
• Last Update Posted: February 18, 2009
• Sponsor: Southeast University, China
• Collaborator: Nanjing Medical University
• Information provided by: Southeast University, China

Tracking Information

• First Submitted Date: October 14, 2008
• First Posted Date: October 16, 2008
• Last Update Posted Date: February 18, 2009
• Study Start Date: December 2008
• Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Acute Respiratory Distress Syndrome
• Adrenal Insufficiency

Intervention

• Drug: hydrocortisone
  hydrocortisone 100mg q8h
  Other Names:

  • glucocorticoid
  • cortical hormone
• Drug: placebo
  normal saline 100ml q8h

Study Arms

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 17, 2009): 100
• Original Estimated Enrollment (submitted: October 15, 2008): 80
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00773058
• Other Study ID Numbers: QHB-YY 2008
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. QIU Hai-bo, Chinese Medical Association
• Study Sponsor: Southeast University, China
• Collaborators: Nanjing Medical University
• Investigators: Not Provided
• PRS Account: Southeast University, China
• Verification Date: January 2009