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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.
 
ClinicalTrials.gov Identifier: NCT00295269
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : May 9, 2006
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE February 21, 2006
First Posted Date  ICMJE February 23, 2006
Last Update Posted Date May 9, 2006
Study Start Date  ICMJE March 1997
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
Mortality rates (measured at time of hospital discharge or 60 days after study entry)
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2006)
Mortality rates at time of hospital discharge or 60 days after study entry
Change History Complete list of historical versions of study NCT00295269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2006)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2006)
  • Number of ventilator-free days at 28 days following study entry
  • Number of organ failure-free days at 28 days following study entry
  • Reduction in markers of ongoing inflammation and fibroproliferation at 7 days following study entry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Official Title  ICMJE Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Lung Diseases
Intervention  ICMJE Drug: Mythylprednisolone
Study Arms  ICMJE Not Provided
Publications * Steinberg KP, Hudson LD, Goodman RB, Hough CL, Lanken PN, Hyzy R, Thompson BT, Ancukiewicz M; National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Efficacy and safety of corticosteroids for persistent acute respiratory distress syndrome. N Engl J Med. 2006 Apr 20;354(16):1671-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: February 21, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00295269
Other Study ID Numbers  ICMJE 355
N01 HR46054
N01 HR46055
N01 HR46056
N01 HR46057
N01 HR46058
N01 HR46059
N01 HR46060
N01 HR46061
N01 HR46062
N01 HR46063
N01 HR46064
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP