Acute Respiratory Distress SyndromePhase 4NCT00773058
Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)
A Phase 4 study testing hydrocortisone in people with Acute Respiratory Distress Syndrome and Adrenal Insufficiency, run by Southeast University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Adrenal Insufficiency
- What is being tested?
- hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Apr 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994
- 18 to 85 year old
Who cannot join
- 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
About this study
Official title: Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency
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.
- Being tested
- hydrocortisone, placebo
- Keywords
- acute respiratory distress syndrome, glucocorticoid, adrenal insufficiency
- Medical subject headings
- Respiratory Distress Syndrome, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
Also called glucocorticoid, cortical hormone
hydrocortisone 100mg q8h
placeboDrug
normal saline 100ml q8h
| Study group | Role | What they receive |
|---|---|---|
| glucocorticoid+RAI | Active comparator | stress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI Receives: Drug: hydrocortisone |
| placebo + RAI | Placebo comparator | no glucocorticoid But ATCH test hints RAI Receives: Drug: placebo |
| glucocorticoid | Active comparator | stress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI Receives: Drug: hydrocortisone |
| placebo | Placebo comparator | no glucocorticoid But ATCH test does not hint RAI Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994
Measured: within the first 3 days after surgery onset of ARDS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773058
- Sponsor's protocol ID
- QHB-YY 2008
- Status last verified
- Jan 2009
- First submitted
- 14 Oct 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With Stress-Doses Glucocorticoid on Mortality in Patients With ARDS and Relative Adrenal Insufficiency
- ClinicalTrials.gov ID
- NCT00773058
- Acronym / sponsor ID
- QHB-YY 2008
- Keywords
- acute respiratory distress syndrome, glucocorticoid, adrenal insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Nanjing Medical University
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (estimated)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| glucocorticoid+RAI | Active comparator | Drug: hydrocortisonestress-dose glucocorticoid treatment, compared to placebo group and ACTH test hints RAI |
| placebo + RAI | Placebo comparator | Drug: placebono glucocorticoid But ATCH test hints RAI |
| glucocorticoid | Active comparator | Drug: hydrocortisonestress-dose glucocorticoid treatment, compared to placebo group and ACTH test does not hint RAI |
| placebo | Placebo comparator | Drug: placebono glucocorticoid But ATCH test does not hint RAI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994
- 18 to 85 year old
Key exclusion criteria (8 listed)
- pregnancy or lactation
- tumor or other immunologic disease
- immunosuppressive drug used
- bone marrow or lung transplantation
- primary or secondary disease of adrenal gland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisoneAlso: glucocorticoid, cortical hormonehydrocortisone 100mg q8h | Drug | glucocorticoid, glucocorticoid+RAI |
| placebonormal saline 100ml q8h | Drug | placebo, placebo + RAI |
Primary outcome
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994
Time frame: within the first 3 days after surgery onset of ARDS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydrocortisone in people with Acute Respiratory Distress Syndrome and Adrenal Insufficiency, run by Southeast University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definite ARDS confirmed by AECC criteria in 1994 (time frame: within the first 3 days after surgery onset of ARDS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.