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

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT00201409

Run by

University of Michigan

People needed

132

Starts

2004-07-01

Expected to finish

2009-06-01

Last updated by the study team

2015-12-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Health Sciences Center — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.