Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome
The purpose of this study is to determine whether the 2mg/kg administration of corticosteroids, in the form of methylprednisolone sodium succinate, in early phase acute respiratory distress syndrome after thoracic surgery, will reduce the postoperative mortality.
Acute Respiratory Distress Syndrome
Acute Lung Injury
Drug: Methylprednisolone sodium succinate
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START)|
- the percentage of patients alive at postoperative 30 day; Patients discharged alive from the hospital in unassisted breathing before 60 days
- the percentage of ventilator-free patients at 7 days from study entry; the percentage of oxygen-independent patients at 21 days following study entry; response of inflammatory mediators to the novel treatment; pulmonary function in ARDS survivors
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||December 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290602
|Korea, Republic of|
|National Cancer Center|
|Goyang, Gyeonggi, Korea, Republic of, 411-769|
|Principal Investigator:||Jae Ill Zo, MD, PhD||National Cancer Center, Korea|