Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

January 16, 2007 updated by: National Cancer Center, Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 411-769
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Jae Ill Zo, MD, PhD, National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (ESTIMATE)

February 13, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2007

Last Update Submitted That Met QC Criteria

January 16, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCCTS-04-087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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