Status:
COMPLETED
Significance of Biological Markers in Patients With Acute Lung Injury/Acute Respiratory Disease
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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 nove...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00217880
Start Date
July 1 2004
End Date
June 1 2009
Last Update
August 19 2013
Active Locations (2)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
University of Michigan
Ann Arbor, Michigan, United States, 48109