Evaluating Smoflipid for treating sepsis

The LIPid Intensive Drug Therapy for Sepsis ¬Pilot (LIPIDS-P) Phase I/II Trial

This study is testing if a new fat-based treatment called Smoflipid can help raise cholesterol levels and improve health in people with sepsis and some organ issues.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Jacksonville, Florida and 2 other locations)
• Trial ID: NCT03405870 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to assess the safety and efficacy of Smoflipid, a lipid injectable emulsion, in elevating cholesterol levels in patients diagnosed with sepsis and moderate organ dysfunction. The study will focus on patients within the first 24 hours of sepsis recognition and will evaluate the drug's ability to raise cholesterol levels, as well as its impact on organ dysfunction, mortality, and biological activity. Participants will be monitored for any adverse effects and overall clinical outcomes over a specified period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with sepsis within 24 hours and have a SOFA score of 4 or higher.

Not a fit: Patients with severe hyperlipidemia, significant traumatic brain injury, or alternative diagnoses causing shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel approach to improving outcomes in patients suffering from sepsis by enhancing their cholesterol levels.

How similar studies have performed: While the approach of using lipid emulsions in sepsis is promising, this specific application of Smoflipid is novel and has not been extensively tested in prior studies.

Eligibility 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

Where this trial is running

Jacksonville, Florida and 2 other locations

• Department of Emergency Medicine, UF Health Jax ICU/MICU — Jacksonville, Florida, United States (RECRUITING)
• UF Health Jacksonville — Jacksonville, Florida, United States (RECRUITING)
• UF Health Jacksonville North campus — Jacksonville, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Faheem W Guirgis, MD — University of Florida
• Study coordinator: Faheem W Guirgis, MD

Conditions: Sepsis, Severe, Septic Shock, cholesterol, lipids, total parenteral nutrition