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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00295269
First received: February 21, 2006
Last updated: May 8, 2006
Last verified: April 2006
  Purpose

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 Intervention Phase
Acute Respiratory Distress Syndrome
Lung Diseases
Drug: Mythylprednisolone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

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

Estimated Enrollment: 200
Study Start Date: March 1997
Estimated Study Completion Date: September 2005
Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295269

Sponsors and Collaborators
Investigators
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
Principal Investigator: Galen Toews University of Michigan
Principal Investigator: Arthur Wheeler Vanderbilt University
Principal Investigator: Herbert Wiedemann The Cleveland Clinic
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00295269     History of Changes
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
Study First Received: February 21, 2006
Last Updated: May 8, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Disease
Pathologic Processes
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on October 01, 2014