A Randomized Trial of GM-CSF in Patients With ALI/ARDS

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborators: Emory University; National Heart, Lung, and Blood Institute (NHLBI); University of Colorado, Denver

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