Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

NCT00290602 | Completed Phase 2

• 1 other identifier: NCCCTS-04-087
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome; Acute Lung Injury; Postoperative Complications

Keywords

Acute respiratory distress syndrome; corticosteroids; postoperative complications; cytokines

Outcome Measures

Primary Outcomes (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)

• 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

Interventions

Methylprednisolone sodium succinate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Clinical evidence of active and untreated infection.
• Clarifications:
• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

Related Publications (2)

• 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.

  PMID: 15680804 BACKGROUND

• 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.

  PMID: 16374152 BACKGROUND

Related Links

• ARDS network
• National Cancer Center Korea

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury; Postoperative Complications

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jae Ill Zo, MD, PhD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: February 1, 2004
• Study Completion: December 1, 2006
• Last Updated: January 17, 2007

Record last verified: 2007-01

Locations

KR (1)