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

Terminated

• Conditions: Acute Respiratory Distress Syndrome

• Registration Number: NCT01093287
• Lead Sponsor: Samsung Medical Center

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-10
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of