At a glance
ClinicalIndex Comparison Record- ✓PaO2/FiO2 ratio <300 (ALI) or <200 (ARDS)
- ✓Bilateral infiltrates on frontal chest radiograph consistent with pulmonary edema
- ✓Requires positive pressure ventilation via endotracheal tube
- ✓No clinical evidence of left atrial hypertension (pulmonary arterial wedge pressure ≤18 mm Hg)
- ✕Greater than 7 days elapsed following institution of mechanical ventilation
- ✕Chronic respiratory failure (FEV1 <20 ml/kg PBW or FEV1/FVC <50%)
- ✕Chronic hypercapnia or hypoxemia
- ✕Hospitalization within past 6 months for acute respiratory failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
In Brief
A Phase 2 clinical trial evaluating Placebo and GM-CSF for Respiratory Distress Syndrome, Adult. Completed, enrolled 132 participants across 3 sites.
Detailed 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) will improve the clinical course and outcome by shortening the duration of mechanical ventilation for these patients.
Study Details
Timeline
Interventions
Placebo will be administered by slow intravenous infusion once daily for 14 days.
Recombinant human GM-CSF (250 mcg/M2) will be administered by slow intravenous infusion once daily for 14 days.