Effect of Treatment With Stress-Doses Glucocorticoid in P... | NCT00773058

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

NCT00773058

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Feb 18, 2009Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Acute Respiratory Distress Syndrome
Adrenal Insufficiency

Interventions

hydrocortisone
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Apr 2009Estimated

Completion Date

Not provided

First Submitted Date

Oct 14, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Name	Class
Nanjing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
hydrocortisone	Drug	hydrocortisone 100mg q8h	glucocorticoid glucocorticoid+RAI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994		within the first 3 days after surgery onset of ARDS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Aug 29, 2011
Reset	Oct 3, 2011

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 29, 2011			Oct 3, 2011

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D000309	Adrenal Insufficiency

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D000307	Adrenal Gland Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006854	Hydrocortisone
D005938	Glucocorticoids

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided