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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2005-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Distress Syndrome Lung Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mythylprednisolone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Edward Abraham

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

William Fulkerson

Role: PRINCIPAL_INVESTIGATOR

Duke University

Leonard Hudson

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Paul Lanken

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Michael Matthay

Role: PRINCIPAL_INVESTIGATOR

University of California

Alan Morris

Role: PRINCIPAL_INVESTIGATOR

Latter Day Saints Hospital

David Schoenfeld

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Henry Silverman

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Galen Toews

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Arthur Wheeler

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Herbert Wiedemann

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT

PMID: 16625008 (View on PubMed)