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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093287
First Posted: March 25, 2010
Last Update Posted: June 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gee Young Suh, Samsung Medical Center
  Purpose
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 .

Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Gee Young Suh, Samsung Medical Center:

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients meeting the American European Consensus definition of acute respiratory distress syndrome will be included, regardless of etiology of respiratory failure.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093287


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gee Young Suh, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01093287     History of Changes
Other Study ID Numbers: 2009-08-075
First Submitted: March 24, 2010
First Posted: March 25, 2010
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury