Status:
COMPLETED
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This study will test the hypothesis that administration of granulocyte-macrophage colony stimulating factor (GM-CSF) to patients with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) w...
Detailed Description
BACKGROUND: Respiratory failure due to ALI/ARDS remains a major health problem, despite significant progress in intensive care unit care and ventilator management. ALI/ARDS is characterized by unacce...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
- Requirement for positive pressure ventilation via an endotracheal tube
- No clinical evidence of left atrial hypertension (pulmonary arterial wedge pressure measure up to 18 mm Hg)
- First three criteria must occur together within a 24-hour interval
- Exclusion criteria:
- Greater than 7 days elapsed following institution of mechanical ventilation
- Pregnancy
- Chronic respiratory failure as defined by any of the following: 1) FEV1 less than 20 ml/kg of PBW; or 2) FEV1/FVC less than 50%
- Chronic hypercapnia or hypoxemia
- Hospitalization within the 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
- Neutropenia (absolute neutrophil count less than 1000 cells/mm3)
- History of hematological malignancy or bone marrow transplant
- Entry into other intervention clinical trials
- Decision of the patient or attending physician to forego aggressive care
- Expected survival rate of less than 6 months (based solely on pre-existing medical problems \[i.e., poorly controlled neoplasm or other end-stage disease\])
- AIDS or known history of HIV infection
- Prednisone (or equivalent) therapy greater than or equal to 20 mg/day for a period of not less than 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 or in whom permissive hypercapnia may be otherwise contraindicated
- Neuromuscular disease that would potentially impact ability to wean from mechanical ventilation
- Receiving extracorporeal membrane oxygenation when meeting screening criteria
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00201409
Start Date
July 1 2004
End Date
June 1 2009
Last Update
December 29 2015
Active Locations (3)
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1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80045
2
Emory University
Atlanta, Georgia, United States, 30303
3
University of Michigan
Ann Arbor, Michigan, United States, 48109