Comparative Evaluation of Albumin and Starch Effects in Acute Lung Injury (ALI)
Status:
Terminated
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
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 Office of Orphan Products Development (OOPD)