Significance of Biological Markers in Patients With Acute Lung Injury/Acute Respiratory Disease
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      The purpose of this study is to identify biological markers of disease in patients with acute
      lung injury (ALI) that are predictive of either disease susceptibility or prognosis, or that
      identify novel targets of therapeutic intervention.
    

Detailed description: 
      BACKGROUND:

      Respiratory failure due to ALI and acute respiratory distress syndrome (ARDS) remains a major
      health problem despite significant progress in intensive care unit (ICU) care and ventilator
      management. It is also characterized by an unacceptably high mortality rate despite enormous
      expenditure of health care resources. Survivors of respiratory failure face long-term
      consequences concerning their quality of life. New therapies are needed to improve early
      survival and to decrease long-term sequelae of this syndrome. The purpose of this study is to
      identify biological markers of disease in patients with ALI that are predictive of either
      disease susceptibility or prognosis, or that identify novel targets of therapeutic
      intervention.

      DESIGN NARRATIVE:

      As soon as possible after case identification, informed consent will be obtained from the
      patient or next of kin. Physiologic measurements and specimen collection will begin at the
      time of entry into the study. The inclusion criteria for this study allow entry of patients
      who have fulfilled criteria for ALI/ARDS for up to 48 hours. Bronchoalveolar lavage (BAL)
      fluid and blood will be collected at various times after the onset of ALI/ARDS in order to
      measure levels of a predetermined set of biological markers. In addition, DNA will be
      collected from patients and analysed for the presence of specific genetic polymorphisms that
      might alter either disease susceptibility or clinical expression of disease. The levels of
      these markers or the presence of specific genetic polymorphisms will be correlated with
      measure of pulmonary inflammation and extent of lung injury, as defined by: 1) PaO2/FiO2
      ratios; 2) lung compliance; 3) plateau pressures; and 4) calculation of the Murray Lung
      Injury Score (obtained at entry and Days 1, 2, 3, 5, 7,10, 14, and 21). Secondary outcome
      measures to be directly correlated with biomarker expression will include indicators of
      maladaptive responses to ALI (including the development of multiple organ dysfunction
      syndrome [MODS]), fibroproliferation, and nosocomial pneumonia (events which greatly impact
      the clinical course of patients with ALI/ARDS). Thus, the secondary outcome measures include:
      1) the development of organ failure (using the Sequential Organ Failure Assessment [SOFA]
      score); 2) time on ventilator; 3) ventilator-free days; 4) ICU and hospital length of stay;
      5) hospital mortality; 6) development of pneumonia; 7) development of lung fibrosis (as
      determined by high-resolution computed tomography [HRCT] and pulmonary function testing); and
      8) health related and lung-specific quality of life (as assessed with the Medical Outcome
      Studies 36-Item Short form Health Survey Standard Form [SF-36] and St. George's Respiratory
      Questionnaire).
    

Intervention name(s): Bronchoscopy
Intervention type(s): Procedure
Intervention description(s): A bronchoscopy test will occur to view the participant's airways.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic