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

Primary Purpose

Acute Respiratory Distress Syndrome, Adrenal Insufficiency

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hydrocortisone
placebo
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring acute respiratory distress syndrome, glucocorticoid, adrenal insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    glucocorticoid+RAI

    placebo + RAI

    glucocorticoid

    placebo

    Arm Description

    stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI

    no glucocorticoid But ATCH test hints RAI

    stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI

    no glucocorticoid But ATCH test does not hint RAI

    Outcomes

    Primary Outcome Measures

    Evidence of clinically definite ARDS confirmed by AECC criteria in 1994

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2008
    Last Updated
    February 17, 2009
    Sponsor
    Southeast University, China
    Collaborators
    Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00773058
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    April 2009 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Southeast University, China
    Collaborators
    Nanjing Medical University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Distress Syndrome, Adrenal Insufficiency
    Keywords
    acute respiratory distress syndrome, glucocorticoid, adrenal insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    glucocorticoid+RAI
    Arm Type
    Active Comparator
    Arm Description
    stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI
    Arm Title
    placebo + RAI
    Arm Type
    Placebo Comparator
    Arm Description
    no glucocorticoid But ATCH test hints RAI
    Arm Title
    glucocorticoid
    Arm Type
    Active Comparator
    Arm Description
    stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    no glucocorticoid But ATCH test does not hint RAI
    Intervention Type
    Drug
    Intervention Name(s)
    hydrocortisone
    Other Intervention Name(s)
    glucocorticoid, cortical hormone
    Intervention Description
    hydrocortisone 100mg q8h
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    normal saline 100ml q8h
    Primary Outcome Measure Information:
    Title
    Evidence of clinically definite ARDS confirmed by AECC criteria in 1994
    Time Frame
    within the first 3 days after surgery onset of ARDS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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

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