Lung Injury, Acute (ALI) Clinical Trial
Official title:
Phase III Study Comparing Albumin and Hetastarch Therapy in Acute Lung Injury
Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are similar
conditions in which the lungs are critically injured by another inflammatory process in the
body. Together they affect more than 150,000 people per year in the United States, with
mortality approaching 50% and a financial burden estimated to exceed $5 billion. Fluid
overload, weight gain, and reduced oncotic pressure (low blood proteins) are associated with
prolonged need for mechanical ventilation and mortality in patients with ALI/ARDS.
Historical studies have provided conflicting evidence for benefits with colloid or diuretic
therapy in ALI/ARDS, but recent clinical trials have demonstrated significant improvements
in blood oxygen levels. The mechanisms of these benefits are not yet certain, but appear to
relate to albumin's (a protein medicine) specific ability to influence injury and
inflammation in the lungs, thus improving the ability for the lung to repair and exchange
oxygen.
The purpose of this project is to determine the effects of therapies that affect blood
proteins on their ability to change the way the lungs and cardiovascular system (heart and
blood vessels) function. Special measurements will be taken to understand how these protein
medicines change the ability of the lung and whole body to recover from widespread injury,
with additional measures of specific heart and lung function. This clinical trial randomizes
ALI/ARDS patients with low blood protein levels to receive albumin (a natural blood protein
that is known to influence inflammation) or hetastarch (a synthetic blood protein) with
diuretic therapy targeted to improve respiratory function. Therapeutic effects on
respiratory function and blood oxygen levels, extravascular lung water, oncotic pressure,
lung fluid removal, and heart function will be characterized. This trial will advance our
understanding of treatment of ALI/ARDS and the factors that affect fluid balance in the
lungs of these patients.
Funding Source - FDA OOPD
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment