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Acute Respiratory Distress SyndromePhase 2NCT00290602

Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

A Phase 2 study testing Methylprednisolone sodium succinate in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by National Cancer Center, Korea at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Methylprednisolone sodium succinate
How many people
40 participants
Where
1 siteSouth Korea
Study dates
Feb 2004to Dec 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
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  • 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.
  • PaO2/FiO2 ≤ 200 on the day of E-START enrollment.

Who cannot join

  • 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.
Show all 17Show fewer
  • Age <18 years.
  • Pregnancy.
  • Burns requiring skin grafting.
  • 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.
  • Other irreversible chronic disease or condition for which 6 month mortality is estimated ≥ 50%.
  • Not committed to full support.
  • Severe chronic liver disease (Child-Pugh Class C score>10 points).
  • Transplant patients with the exception of autologous bone marrow transplants.
  • Extracorporeal support of gas exchange at the time of study entry (e.g., ECMO).
  • Known or suspected adrenal insufficiency.
  • Vasculitis with diffuse alveolar hemorrhage.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 411-769

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Methylprednisolone sodium succinate
Keywords
Acute respiratory distress syndrome, corticosteroids, postoperative complications, cytokines
Medical subject headings
Respiratory Distress Syndrome, Acute Lung Injury, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylprednisolone sodium succinateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  1. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startFeb 2004
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290602
Sponsor's protocol ID
NCCCTS-04-087
Status last verified
Jan 2007
First submitted
10 Feb 2006
Last updated
17 Jan 2007
Results posted
No

Publications

  • Lee HS, Lee JM, Kim MS, Kim HY, Hwangbo B, Zo JI. Low-dose steroid therapy at an early phase of postoperative acute respiratory distress syndrome. Ann Thorac Surg. 2005 Feb;79(2):405-10. doi: 10.1016/j.athoracsur.2004.07.079.

    PubMed 15680804

  • Annane D, Sebille V, Bellissant E; Ger-Inf-05 Study Group. Effect of low doses of corticosteroids in septic shock patients with or without early acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):22-30. doi: 10.1097/01.ccm.0000194723.78632.62.

    PubMed 16374152

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Methylprednisolone sodium succinate in people with Acute Respiratory Distress Syndrome and Acute Lung Injury, run by National Cancer Center, Korea at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the percentage of patients alive at postoperative 30 day; Patients discharged alive from the hospital in unassisted breathing before 60 days. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00290602, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2007.

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