NCT00290602

Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Respiratory Distress Syndrome
• Acute Lung Injury
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Methylprednisolone sodium succinate

Timeline

• Start date: 2004-02-01
• Completion: 2006-12-01
• First posted: 2006-02-13
• Last updated: 2007-01-17

Locations

1 site across 1 country: South Korea