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

NCT01093287 | Terminated

• 1 other identifier: 2009-08-075
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25510776 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 25, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

KR (1)