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Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295269
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : May 9, 2006
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Lung Diseases Drug: Mythylprednisolone Phase 3

Detailed Description:


ARDS affects approximately 150,000 people in the United States each year. Despite twenty years of research into the mechanisms that cause this syndrome and numerous developments in the technology of mechanical ventilation, the mortality rate has remained greater than 50 percent. In addition to the tragic loss of human life, this condition poses a cost to society because these patients spend an average of two weeks in intensive care units and require multiple high tech procedures. Because of the overwhelming nature of the lung injury once it is established, prevention appears to be the most effective strategy for improving the outlook for those with ARDS.

Basic research has identified numerous inflammatory pathways that are associated with the development of ARDS. Agents that block these mediators prolong survival in animals with lung injury, and a few of them have been tested in human patients. Because of the large number of putative mediators and the variety of ways that their action can be blocked, the possibility for new drug development is almost infinite. This is an exciting prospect, since it envisions the first effective pharmacologic treatment for ARDS. However, preliminary clinical studies have shown conflicting results, and there is an urgent need for a mechanism to efficiently and effectively test new drugs in ARDS. Treatment studies in patients with ARDS are difficult to perform for three reasons. First, the complicated clinical picture makes it difficult to accumulate a large number of comparable patients in any one center. Secondly, there is no agreement on the optimal supportive care of these critically ill patients. Finally, many of the patients meeting study criteria will not be enrolled in study protocols because of the acute nature of the disease process. For these reasons, therapeutic trials in ARDS require multicenter cooperation.


This study compared the effect of corticosteroids with placebo in the management of late-phase (greater than seven days) ARDS. The study determined if the administration of the corticosteroid, methylprednisolone sodium succinate, in severe ARDS that was either stable or worsening after seven days, would reduce mortality and morbidity. The primary endpoint was mortality at 60 days. Secondary endpoints included ventilator-free days and organ failure-free days. LaSRS was designed to include 400 patients and began recruiting in the Spring of 1997. In October 1999, the data and safety monitoring board (DSMB) reduced the recruitment target number to 200 patients because the eligible patients were fewer than anticipated.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Study Start Date : March 1997
Study Completion Date : September 2005

Primary Outcome Measures :
  1. Mortality rates (measured at time of hospital discharge or 60 days after study entry)

Secondary Outcome Measures :
  1. Number of ventilator-free days (measured at 28 days following study entry)
  2. Number of organ failure-free days (measured at 28 days following study entry)
  3. Reduction in markers of ongoing inflammation and fibroproliferation (measured at 7 days following study entry)

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with ARDS or has risk factors for ARDS; individuals will be considered at risk if they are critically ill and have trauma, sepsis, shock, pneumonia, inhalation injury, drug overdose, pancreatitis, or hypertransfusion
  • Onset of ARDS must be between 7 and 28 days prior to study entry
  • Since ARDS onset, bilateral infiltrates must have persisted and participants must have required continuous mechanical ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295269

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Edward Abraham University of Colorado, Denver
Principal Investigator: William Fulkerson Duke University
Principal Investigator: Leonard Hudson University of Washington
Principal Investigator: Paul Lanken University of Pennsylvania
Principal Investigator: Michael Matthay University of California
Principal Investigator: Alan Morris Latter Day Saints Hospital
Principal Investigator: David Schoenfeld Massachusetts General Hospital
Principal Investigator: Henry Silverman University of Maryland, College Park
Principal Investigator: Galen Toews University of Michigan
Principal Investigator: Arthur Wheeler Vanderbilt University
Principal Investigator: Herbert Wiedemann The Cleveland Clinic
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00295269    
Other Study ID Numbers: 355
N01 HR46054
N01 HR46055
N01 HR46056
N01 HR46057
N01 HR46058
N01 HR46059
N01 HR46060
N01 HR46061
N01 HR46062
N01 HR46063
N01 HR46064
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: May 9, 2006
Last Verified: April 2006
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pathologic Processes
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury