Fatigue Clinical Trial
Official title:
A Phase II, Double-Blind, Placebo-Controlled, Randomized Study of the Effects of a Lipid Emulsion (Lipidose) on Endotoxin Levels in Patients on Chronic Hemodialysis
The purpose of this study is to determine whether a phospholipid emulsion is effective in the treatment of chronic endotoxemia in hemodialysis patients.
Over 70% of dialysis patients suffer chronically from severe fatigue and tiredness. A
possible inciting factor may be high levels of circulating endotoxin, which is
well-established as a potent stimulator of inflammatory cytokine release.
The source of increased endotoxin in dialysis patients remains unclear, with the most
popular hypotheses including back-diffusion of bacterial products from nonsterile dialysate
and translocation of bacterial products across what in most dialysis patients is an
edematous gut wall. This endotoxin does not appear to be associated with the dialysis
procedure itself and indeed, appears to be cleared with some efficiency by the procedure.
However, by the next dialysis treatment, endotoxin levels rise rapidly to levels that are in
some cases significantly higher than even those measured (via EAA) in patients suffering
from septic shock. Although the mechanisms by which dialysis patients tolerate these high
endotoxin levels without hemodynamic collapse are not understood, high levels have been
shown by The Rogosin Institute to significantly correlate with patient fatigue.
Given the potent ability of endotoxin to induce expression of inflammatory cytokines (which
in turn are likely responsible for the debilitating symptoms of fatigue and malaise that
afflict the majority of the dialysis population), it is logical that binding and
inactivation of endotoxin may lead to improved clinical outcomes. Unfortunately, there are
no products currently approved for this purpose in dialysis patients.
One approach to this problem may be to augment the endogenous systems for endotoxin
inactivation. For example, it has been suggested that the various serum lipoprotein
fractions may in fact be a physiologic "sink" for endotoxin (and other toxins) via binding
with surface phospholipids. Therefore, dialysis patients, who as a population are
characterized with hypocholesterolemia and hypolipoproteinemia, are particularly at risk for
the deleterious effects of endotoxemia.
This has led to the development of "LIPIDOSE," a protein-free phospholipid emulsion. The
proposed mechanism of action of this compound is via remodeling of the infused phospholipids
into lipoproteins, thereby increasing lipoprotein and phospholipid content and facilitating
greater endotoxin binding and neutralization. "LIPIDOSE" has undergone extensive testing in
both animals and humans, and has been found to significantly increase serum phospholipid and
lipoprotein concentrations, improve survival in a lethal animal model of septic peritonitis,
and mitigate the symptoms of endotoxemia in healthy volunteers.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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