LIPIDS-P Trial Phase I/II

Eligibility Criteria

• 1. age \> 18,
• 2. primary diagnosis of sepsis and within 24 hours of sepsis recognition and treated with institutional sepsis algorithm,
• 3. SOFA score ≥ 4,
• 4. screening total cholesterol ≤ 100 mg/dL or HDL-C + LDL-C ≤ 70 mg/dL
• 1. total bilirubin \> 2 mg/dL,
• 2. serum albumin \< 1.5 mg/dL,
• 3. hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients,
• 4. severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides \> 400 mg/dL,
• 5. alternative/confounding diagnosis causing shock or critical illness (e.g., myocardial infarction or pulmonary embolus, massive hemorrhage, trauma),
• 6. significant traumatic brain injury (evidence of neurologic injury on CT scan and a GCS \<8),
• 7. refractory shock (likely death within 12 hours),
• 8. established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable,
• 9. anticipated requirement for surgery that would interfere with drug infusion,
• 10. severe primary blood coagulation disorder,
• 11. acute pancreatitis accompanied by hyperlipidemia,
• 12. acute thromboembolic disease,
• 13. uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
• 14. severe immunocompromised state (e.g. subject has neutropenia receiving cytotoxic chemotherapy with absolute neutrophil count \< 500/ul or expected to decline to \< 500/uL within the next 3 days),
• 15. pregnancy or lactation
• 16. already receiving intravenous lipid formulations (e.g., TPN, propofol) will be excluded from the study as lipid infusion will interfere with interpretation of the study results.
• 17. Child Pugh Class B/C liver disease patients or liver transplant recipient
• 18. Patients on, or anticipated to be placed on, ECMO within 48 hours of enrollment