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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Southeast University, China.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Nanjing Medical University
Information provided by:
Southeast University, China
ClinicalTrials.gov Identifier:
NCT00773058
First received: October 14, 2008
Last updated: February 17, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome
Adrenal Insufficiency
Drug: hydrocortisone
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Evidence of clinically definite ARDS confirmed by AECC criteria in 1994 [ Time Frame: within the first 3 days after surgery onset of ARDS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr. QIU Hai-bo, Chinese Medical Association
ClinicalTrials.gov Identifier: NCT00773058     History of Changes
Other Study ID Numbers: QHB-YY 2008
Study First Received: October 14, 2008
Last Updated: February 17, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Southeast University, China:
acute respiratory distress syndrome
glucocorticoid
adrenal insufficiency

Additional relevant MeSH terms:
Acute Lung Injury
Adrenal Insufficiency
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Adrenal Gland Diseases
Disease
Endocrine System Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Cortisol succinate
Glucocorticoids
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014