LIPIDS-P Trial Phase I/II

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Briefly, this pilot clinical trial will evaluate preliminary safety and efficacy of the study drug (Smoflipid) at elevating cholesterol levels (primary outcome) in patients with sepsis and moderate organ dysfunction and will also evaluate measures of organ dysfunction, mortality, and biological activity (secondary outcomes).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Fresenius Kabi
• Treatments: SMOFlipid

Criteria

Inclusion 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

Exclusion Criteria:

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