Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START)
The acute respiratory distress syndrome (ARDS) developing after thoracic surgery is usually
a lethal complication. The use of corticosteroid in ARDS has been the subject of great
controversy and debate over the years. Unfortunately, trials of short-term, high-dose
steroid therapy failed to show an improvement in mortality of patients at risk of, or with
early, ARDS. Several investigators have suggested that the use of corticosteroids in the
late or fibroproliferative phase of ARDS improved lung function and survival.
Recently some authors have demonstrated that there is a potential for pulmonary
fibroproliferation during the early stages of ARDS and the use of low-dose corticosteroids
at these early stages has been found to lead to a complete maintenance of in vivo and in
vitro respiratory mechanics in acute lung injury. These articles had important implications
both for the study of repair mechanisms and the timing of therapies.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the percentage of patients alive at postoperative 30 day; Patients discharged alive from the hospital in unassisted breathing before 60 days
Jae Ill Zo, MD, PhD
Principal Investigator
National Cancer Center, Korea
South Korea: Korea Food and Drug Administration (KFDA)
NCCCTS-04-087
NCT00290602
February 2004
December 2006
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