Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Acute Respiratory Distress Syndrome, Acute Lung Injury, Postoperative Complications

Thank you

Trial Information

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

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.

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

- 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.


- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Jae Ill Zo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

February 2004

Completion Date:

December 2006

Related Keywords:

  • Acute Respiratory Distress Syndrome
  • Acute Lung Injury
  • Postoperative Complications
  • Acute respiratory distress syndrome
  • corticosteroids
  • postoperative complications
  • cytokines
  • Postoperative Complications
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome, Adult
  • Acute Lung Injury
  • Lung Injury