Lipid Infusion in Dialysis Patients With Endotoxemia

Inclusion Criteria

• On hemodialysis for ≥ 3 months.
• Provided written and dated informed consent.
• Meets the following lab parameters on Screening labs:
• Serum albumin > 2.5 g/dL;
• Serum total cholesterol > 95 mg/dL;
• Serum High-Density Lipoprotein (HDL) > 20 mg/dL;
• Serum hemoglobin ≥ 11 g/dL;
• Serum transaminases 300 U/L;
• Low-Density Lipoprotein (LDL) > 190 mg/dL;
• Fasting (8 hours, water only) triglyceride level > 300 mg/dL;
• Serum phospholipid level > 500 mg/dL.
• Has an EAA level 460 msec in males and > 470 msec in females) on screening electrocardiogram (ECG).
• Has a history of allergic reaction to eggs (or egg products), soybeans, Intralipid, or any component of "LIPIDOSE".
• Has had a recent hospitalization (within the last 30 days) or has other acute illness.
• Deemed not medically or psychiatrically stable for the study (in opinion of investigator or the subject's primary nephrologist).
• Currently on any of the following medications: (a) medications known to cause QT prolongation; (b) parenteral nutrition supplements (e.g., Intralipid); (c)amphotericin; (d) liposomal amphotericin; (e) amphotericin B lipid complex; or (f) coumadin.
• Has known preexisting systolic dysfunction (as defined by previous echocardiogram with ejection fraction (EF) < 35%).
• Currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid "emulsion" (e.g., Intralipid), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.
• Has a known active hemolytic disease; immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major) or is known or believed to suffer from hereditary spherocytosis or S.E. Asian elliptocytosis.
• Has a known bone marrow disorder of inadequate red cell production (e.g., aplastic anemia, myelodysplasia).
• Has known current alcohol or drug abuse.