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Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Lung Injury, Postoperative Complications

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Methylprednisolone sodium succinate
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, corticosteroids, postoperative complications, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • National Cancer Center

Outcomes

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

Full Information

First Posted
February 10, 2006
Last Updated
January 16, 2007
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00290602
Brief Title
Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome
Official Title
Prospective Phase II Study of Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome (ARDS) After Thoracic Surgery (E-START)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Center, Korea

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Lung Injury, Postoperative Complications
Keywords
Acute respiratory distress syndrome, corticosteroids, postoperative complications, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Methylprednisolone sodium succinate
Primary Outcome Measure Information:
Title
the percentage of patients alive at postoperative 30 day; Patients discharged alive from the hospital in unassisted breathing before 60 days
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Ill Zo, MD, PhD
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
411-769
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15680804
Citation
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.
Results Reference
background
PubMed Identifier
16374152
Citation
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.
Results Reference
background
Links:
URL
http://www.ardsnet.org
Description
ARDS network
URL
http://www.ncc.re.kr
Description
National Cancer Center Korea

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Early Low Dose Steroid Therapy of Acute Respiratory Distress Syndrome

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