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Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290602
First Posted: February 13, 2006
Last Update Posted: January 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Center, Korea
  Purpose
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • the percentage of patients alive at postoperative 30 day; Patients discharged alive from the hospital in unassisted breathing before 60 days

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: February 2004
Estimated Study Completion Date: December 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ARDS, defined as the acute onset of:

    • PaO2/FiO2 ≤ 200.
    • Bilateral infiltrates. The infiltrates may be patchy, diffuse, homogeneous, or asymmetric, and should be consistent with pulmonary edema or the fibrotic changes of fibroproliferation. Opacities due to pleural effusions or atelectasis should not be considered. If pneumonectomy, unilateral infiltrate is included.
    • No evidence of left atrial hypertension. If measured, PAWP ≤ 18 mmHg.
    • Criteria a-c must occur together within a 24-hour interval. The first date that these criteria are met is defined as the onset of ARDS
  2. Since ARDS onset, chest infiltrates must be progressive, and chest computed tomographic scan findings are consistent with postoperative ARDS findings or ground glass opacities by radiologists.
  3. Major thoracic surgery

    • Lung cancer; pneumonectomy, extended pneumonectomy, lobectomy, sleeve lobectomy, extended lobectomy, wedge resection.
    • Esophageal cancer; Ivor-Lewis operation, transhiatal esophagectomy, McKeown operation.
    • Metastatic lung cancer; simultaneous bilateral metastasectomy.
  4. PaO2/FiO2 ≤ 200 on the day of E-START enrollment.

Exclusion Criteria:

  1. Clinical evidence of active and untreated infection.

    Clarifications:

    • A known, undrained abscess (e.g. Staphylococcal lung abscess or loculated empyema or intra-abdominal abscess) or a known intravascular nidus of infection (e.g., bacterial or fungal endocarditis) will be a basis for exclusion, even if it is being treated with antibiotics.
    • A bacterial infection being treated with a standard antibiotic regimen would not be a basis for exclusion.
    • Disseminated fungal infection, even if being treated, is an exclusion.
    • Ongoing septic shock, even if on antibiotics is a basis for exclusion.
  2. Age <18 years.
  3. Pregnancy.
  4. Burns requiring skin grafting.
  5. Patients with AIDS by CDC criteria, diagnosed by either a documented AIDS defining illness or CD4<200(see Appendix F); prednisolone therapy >=300mg(or its equivalent) cumulative dose within 21 days prior to enrollment, or >15mg/day(or its equivalent) within 7 days prior to enrollment; cytotoxic therapy within 3 weeks.
  6. Other irreversible chronic disease or condition for which 6 month mortality is estimated ≥ 50%.
  7. Not committed to full support.
  8. Severe chronic liver disease (Child-Pugh Class C score>10 points).
  9. Transplant patients with the exception of autologous bone marrow transplants.
  10. Extracorporeal support of gas exchange at the time of study entry (e.g., ECMO).
  11. Known or suspected adrenal insufficiency.
  12. Vasculitis with diffuse alveolar hemorrhage.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290602


Locations
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi, Korea, Republic of, 411-769
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Jae Ill Zo, MD, PhD National Cancer Center, Korea
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00290602     History of Changes
Other Study ID Numbers: NCCCTS-04-087
First Submitted: February 10, 2006
First Posted: February 13, 2006
Last Update Posted: January 17, 2007
Last Verified: January 2007

Keywords provided by National Cancer Center, Korea:
Acute respiratory distress syndrome
corticosteroids
postoperative complications
cytokines

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Injury
Postoperative Complications
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones