CompletedPhase 1/2

LIPIDS-P Trial Phase I/II Trial

United States59 participantsStarted 2018-08-17

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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 \< 1.5 mg/dL,
✕. hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients,
✕. severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides \> 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,

What they're measuring

Phase II - Primary Outcome - Change in Total Cholesterol (48 Hours - Enrollment)

Timeframe: 48 hours

Phase I - Primary Outcome - Maximum Tolerated Dose/Participants Experiencing Dose Related Toxicity

Timeframe: First 48 hours

Trial details

NCT IDNCT03405870

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-26

Results submitted2023-06-16

View on ClinicalTrials.gov More Sepsis, Severe trials