Acute Respiratory Distress SyndromeNCT01093287
Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients meeting the American European Consensus definition of acute respiratory distress syndrome will be included, regardless of etiology of respiratory failure.
Who may be able to join
- AECC definition of acute respiratory distress syndrome
- Early acute respiratory distress syndrome (within 72 h of diagnosis)
- PF ratio < 200 at PEEP ≥ 8 cmH2O
Who cannot join
- Imminent death
- Contraindication to corticosteroid treatment
- Already on more than 0.5 mg/kg of methylprednisolone or its equivalent
- Evidence of uncontrolled infection
- Refusal of managing physician to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and intensive care unit stay. However, glucocorticoids may induce serious adverse events and these adverse events might compensate the positive effect of prolonged methylprednisolone infusion and discourage physicians from treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to continue or not prolonged methylprednisolone infusion and this could reduce the drug related adverse events. We project to evaluate the predictors of responsiveness to prolonged methylprednisolone infusion in early acute respiratory distress syndrome .
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gee Young Suh, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093287
- Sponsor's protocol ID
- 2009-08-075
- Status last verified
- Jun 2012
- First submitted
- 24 Mar 2010
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeon K, Chung CR, Yang JH, Park CM, Suh GY. Predictors of response to corticosteroid treatment in patients with early acute respiratory distress syndrome: results of a pilot study. Yonsei Med J. 2015 Jan;56(1):287-91. doi: 10.3349/ymj.2015.56.1.287.
PubMed 25510776
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01093287
- Acronym / sponsor ID
- 2009-08-075
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Mar 2010 (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.
In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and intensive care unit stay. However, glucocorticoids may induce serious adverse events and these adverse events might compensate the positive effect of prolonged methylprednisolone infusion and discourage physicians from treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to continue or not prolonged methylprednisolone infusion and this could reduce the drug related adverse events. We project to evaluate the predictors of responsiveness to prolonged methylprednisolone infusion in early acute respiratory distress syndrome .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the American European Consensus definition of acute respiratory distress syndrome will be included, regardless of etiology of respiratory failure.
Key inclusion criteria (3 listed)
- AECC definition of acute respiratory distress syndrome
- Early acute respiratory distress syndrome (within 72 h of diagnosis)
- PF ratio < 200 at PEEP ≥ 8 cmH2O
Key exclusion criteria (5 listed)
- Imminent death
- Contraindication to corticosteroid treatment
- Already on more than 0.5 mg/kg of methylprednisolone or its equivalent
- Evidence of uncontrolled infection
- Refusal of managing physician to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
- Derived from this study: PubMed 25510776Jeon K, Chung CR, Yang JH, Park CM, Suh GY. Predictors of response to corticosteroid treatment in patients with early acute respiratory distress syndrome: results of a pilot study. Yonsei Med J. 2015 Jan;56(1):287-91. doi: 10.3349/ymj.2015.56.1.287.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093287, which also lists 1 linked publication.
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 12 Jun 2012.