Significance of Biological Markers in Patients With Acute Lung Injury/Acute Respiratory Disease

Completed · Not applicable

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT00217880

Run by

University of Michigan

People needed

40

Starts

2004-07-01

Expected to finish

2009-06-01

Last updated by the study team

2013-08-19

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute onset of illness with:
• PaO2/FiO2 ratio of less than 300 (ALI) or PaO2/FiO2 ratio of less than 200 (ARDS)
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric)
• Positive pressure ventilation via an endotracheal tube
• No clinical evidence of left atrial hypertension (if measured, pulmonary arterial wedge pressure less than or equal to 18 mm Hg)
• First three criteria must occur together within a 24-hour interval

You may not qualify if…

• Greater than 48 hours elapsed following institution of mechanical ventilation
• Pregnancy
• Chronic respiratory failure as defined by any of the following:
• FEV1 less than 20 ml/kg of PBW; FEV1/FVC less than 50%
• Chronic hypercapnia or hypoxemia
• Hospitalization within past 6 months for acute respiratory failure
• Chronic home use of oxygen or mechanical ventilation
• Left ventricular failure as defined by New York Heart Association (NYHA) class IV status
• History of hematological malignancy or bone marrow transplantation
• Entry in other intervention clinical trials
• Decision of the patient or attending physician to forego aggressive care
• Expected survival of less than 6 months (based solely on pre-existing medical problems [e.g., poorly controlled neoplasm or other end-stage disease])
• AIDS (known history of HIV infection)
• Prednisone (or equivalent) therapy of 20 mg/day or more for a period of at least 2 months with treatment continuing within 3 weeks prior to screening
• Cytotoxic therapy within 3 weeks of screening
• Morbid obesity defined as greater than 1 kg/c body weight
• At risk for increased intracranial pressure that may result from permissive hypercapnia
• Permissive hypercapnia that is contraindicated
• Neuromuscular disease that would potentially impact ability to wean from mechanical ventilation
• Receiving extracorporeal membrane oxygenation when meeting screening criteria

Where it is running

• Emory University — Atlanta, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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