A Randomized Trial of GM-CSF in Patients With ALI/ARDS
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Intervention: Placebo; GM-CSF
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

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