NCT00773058

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Last Updated

February 18, 2009

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

October 14, 2008

Last Update Submit

February 17, 2009

Conditions

Acute Respiratory Distress SyndromeAdrenal Insufficiency

Keywords

acute respiratory distress syndromeglucocorticoidadrenal insufficiency

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinically definite ARDS confirmed by AECC criteria in 1994

    within the first 3 days after surgery onset of ARDS

Study Arms (4)

glucocorticoid+RAI

ACTIVE COMPARATOR

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

Drug: hydrocortisone

placebo + RAI

PLACEBO COMPARATOR

no glucocorticoid But ATCH test hints RAI

Drug: placebo

glucocorticoid

ACTIVE COMPARATOR

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

Drug: hydrocortisone

placebo

PLACEBO COMPARATOR

no glucocorticoid But ATCH test does not hint RAI

Drug: placebo

Interventions

hydrocortisoneDRUG

hydrocortisone 100mg q8h

Also known as: glucocorticoid, cortical hormone
glucocorticoidglucocorticoid+RAI
placeboDRUG

normal saline 100ml q8h

placeboplacebo + RAI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994
  • to 85 year old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress SyndromeAdrenal Insufficiency

Interventions

HydrocortisoneGlucocorticoids

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersAdrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 16, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2009

Last Updated

February 18, 2009

Record last verified: 2009-01