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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00201409
• Date of registration: 12/09/2005
• Primary sponsor: University of Michigan
• Public title: A Randomized Trial of GM-CSF in Patients With ALI/ARDS
• Scientific title: A Randomized Trial of GM-CSF in Patients With ALI/ARDS
• Date of first enrolment: July 2004
• Target sample size: 132
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00201409
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Robert C. Hyzy, M.D.
• Affiliation: University of Michigan

• Name: Robert Paine, MD
• Affiliation: University of Utah and University of Michigan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory Distress Syndrome, Adult

Intervention(s)

Drug: GM-CSF

Drug: Placebo

Primary Outcome(s)

Ventilator-free days during Days 1-28 [Time Frame: Measured at Day 28]

Secondary Outcome(s)

Alveolar macrophage function [Time Frame: Measured at Day 28]

Changes in severity of physiologic derangements of respiratory gas exchange [Time Frame: Measured at Day 28]

Incidence of ventilator-associated pneumonia [Time Frame: Measured at Day 28]

Lung epithelial cell integrity [Time Frame: Measured at Day 28]

Non-respiratory organ failure [Time Frame: Measured at Day 28]

Secondary ID(s)

258

P50 HL074024

P50HL074024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Emory University

National Heart, Lung, and Blood Institute (NHLBI)

University of Colorado, Denver