Clinical Trials Directory

Trials / Completed

CompletedNCT00548795

Viral-Related Neutrophil Response and Condition Severity in People With ARDS

A Prospective Assessment of Viral-induced Adaptation of Neutrophil Response in ARDS - Ancillary to ARDS Network Trials

Status
Completed
Phase
Study type
Observational
Enrollment
132 (actual)
Sponsor
National Jewish Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Acute respiratory distress syndrome (ARDS) is a severe lung condition that can result from a bacterial infection in the lungs. Viral infections may impair the body's immune system response to bacteria, which may lead to more serious lung injury. This study will evaluate the association between the immune response and ARDS severity in people who have ARDS plus a viral infection.

Detailed description

ARDS is a serious condition that involves inflammation and fluid accumulation in the lungs, leading to low blood oxygen levels and breathing failure. It is often fatal and affects approximately 150,000 individuals each year in the United States. Common underlying causes include bacterial infections, lung trauma, and pneumonia. Even in people with similar risk factors for ARDS, there are often varying levels of condition severity. This may be because some people experience an ongoing viral infection that further predisposes them to the bacterial infection, worsening the severity of ARDS. Viruses release a protein called Type I interferon. This protein increases the response of the interferon stimulated genes (ISG) in neutrophils, which are white blood cells that protect the body against disease and infections by destroying bacteria. Preliminary studies have shown that some people at risk for ARDS have elevated ISGs in their neutrophils and that ISGs are associated with an impaired neutrophil response and increased severity of ARDS. This study will evaluate the association between viral-related neutrophil ISG response and the severity of ARDS. Participants will include people on mechanical ventilation who are enrolled in either the ARDSNet 06 or 07 studies. For this study, participants will undergo blood collection within 48 hours of beginning the main ARDSNet study. There will be no study visits specifically for this study. Study researchers will analyze participants' blood samples and ARDSNet study data to gather information on mortality, the number of ventilator-free days, markers of severity of organ dysfunction and inflammation, and neutrophil response.

Conditions

Timeline

Start date
2007-08-01
Primary completion
2011-01-01
Completion
2012-07-01
First posted
2007-10-24
Last updated
2020-10-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00548795. Inclusion in this directory is not an endorsement.