Phase 2
N=132
A Randomized Trial of GM-CSF in Patients With ALI/ARDS
Respiratory Distress Syndrome, Adult
Bottom Line
View on ClinicalTrials.gov: NCT00201409 ↗Enrolled (actual)
132
Serious AEs
50.0%
Results posted
Apr 2015
Primary outcome: Primary: Ventilator-free Days During Days 1-28 — 10.8; 10.7 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); GM-CSF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilator-free Days During Days 1-28 |
10.8; 10.7 | — |
| SECONDARY Oxygenation Index Change at Day 15 From Day 1 |
-3.5; -4.6 | — |
| SECONDARY Days Without Organ Failure |
15.7; 12.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00201409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.