Phase 2
N=59
LIPIDS-P Trial Phase I/II Trial
Sepsis, Severe · Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT03405870 ↗Enrolled (actual)
59
Serious AEs
32.1%
Results posted
Aug 2025
Primary outcome: Primary: Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment) — 9; -10; 4; 2 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Smoflipid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment) |
9; -10; 4; 2; -12; 16 | — |
| PRIMARY Phase I - Primary Outcome - Maximum Tolerated Dose/Participants Experiencing Dose Related Toxicity |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Phase II - Secondary Outcome - Organ Dysfunction |
1; 0; -2; -2; 4; -5 | — |
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).
Eligibility Criteria
Inclusion Criteria
- age > 18,
- primary diagnosis of sepsis and within 24 hours of sepsis recognition and treated with institutional sepsis algorithm,
- SOFA score ≥ 4,
- screening total cholesterol ≤ 100 mg/dL or HDL-C + LDL-C ≤ 70 mg/dL
Exclusion Criteria
- total bilirubin > 2 mg/dL,
- serum albumin 400 mg/dL,
- alternative/confounding diagnosis causing shock or critical illness (e.g., myocardial infarction or pulmonary embolus, massive hemorrhage, trauma),
- significant traumatic brain injury (evidence of neurologic injury on CT scan and a GCS <8),
- refractory shock (likely death within 12 hours),
- established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable,
- anticipated requirement for surgery that would interfere with drug infusion,
- severe primary blood coagulation disorder,
- acute pancreatitis accompanied by hyperlipidemia,
- acute thromboembolic disease,
- uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel),
- 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),
- pregnancy or lactation
- 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.
- Child Pugh Class B/C liver disease patients or liver transplant recipient
- Patients on, or anticipated to be placed on, ECMO within 48 hours of enrollment
Data sourced from ClinicalTrials.gov (NCT03405870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.