Status:
COMPLETED
LIPIDS-P Trial Phase I/II Trial
Lead Sponsor:
University of Florida
Conditions:
Sepsis, Severe
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 or...
Detailed Description
Sepsis is a life-threatening disease for which there are no effective treatments. It results from metabolic and immunologic derangements that lead to organ dysfunction, shock and sometimes death. Both...
Eligibility Criteria
Inclusion
- 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
- 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,
- 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
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2023
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT03405870
Start Date
August 17 2018
End Date
April 26 2023
Last Update
August 11 2025
Active Locations (3)
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1
Department of Emergency Medicine, UF Health
Gainesville, Florida, United States, 32610
2
UF Health Emergency Medicine
Gainesville, Florida, United States, 32610
3
UF Health Jacksonville North campus
Jacksonville, Florida, United States, 32218