Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

NCT ID: NCT01093287

Last Updated: 2012-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* AECC definition of acute respiratory distress syndrome
* Early acute respiratory distress syndrome (within 72 h of diagnosis)
* PF ratio \< 200 at PEEP ≥ 8 cmH2O

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Gee Young Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25510776 (View on PubMed)

Other Identifiers

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2009-08-075

Identifier Type: -

Identifier Source: org_study_id

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