Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
Late Steroid Rescue Study (LaSRS): The Efficacy of Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
12 other identifiers
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 1997
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
February 21, 2006
CompletedFirst Posted
Study publicly available on registry
February 23, 2006
CompletedMay 9, 2006
April 1, 2006
February 21, 2006
May 8, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality rates (measured at time of hospital discharge or 60 days after study entry)
Secondary Outcomes (3)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1056/NEJMoa051693.
PMID: 16625008RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 21, 2006
First Posted
February 23, 2006
Study Start
March 1, 1997
Study Completion
September 1, 2005
Last Updated
May 9, 2006
Record last verified: 2006-04