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Sponsored by: |
National Cancer Center, Korea |
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Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00290602 |
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.
Condition | Intervention | Phase |
---|---|---|
Acute Respiratory Distress Syndrome Acute Lung Injury Postoperative Complications |
Drug: Methylprednisolone sodium succinate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START) |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ARDS, defined as the acute onset of:
Major thoracic surgery
Exclusion Criteria:
Clinical evidence of active and untreated infection.
Clarifications:
Korea, Republic of, Gyeonggi | |
National Cancer Center | |
Goyang, Gyeonggi, Korea, Republic of, 411-769 |
Principal Investigator: | Jae Ill Zo, MD, PhD | National Cancer Center, Korea |
Study ID Numbers: | NCCCTS-04-087 |
Study First Received: | February 10, 2006 |
Last Updated: | January 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00290602 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Acute respiratory distress syndrome corticosteroids postoperative complications cytokines |
Respiratory Tract Diseases Postoperative Complications Methylprednisolone Lung Diseases Prednisolone Respiration Disorders |
Respiratory Distress Syndrome, Adult Methylprednisolone acetate Prednisolone acetate Acute respiratory distress syndrome Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones Glucocorticoids |
Protective Agents Neuroprotective Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Syndrome Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |