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Lipid Emulsion

Smoflipid for Sepsis (LIPIDS-P Trial)

Phase 1 & 2
Recruiting
Led By Faheem W Guirgis, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours, 7 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if Smoflipid, a fat given through an IV, can safely raise cholesterol levels in patients with early sepsis. These patients have low cholesterol, making it hard for their bodies to fight the infection. By increasing cholesterol, Smoflipid may help clear toxins and support the body's stress response. An anti-inflammatory lipid injectable emulsion containing fish oil is approved by the Food and Drug Administration as parenteral nutrition for critically ill patients.

Eligible Conditions
  • Sepsis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours, 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours, 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose
Total Cholesterol
Secondary study objectives
HDL function
Lipid Oxidation
Mortality
+1 more

Side effects data

From 2024 Phase 3 trial • 24 Patients • NCT03387579
67%
Anemia
17%
Hypochloremia
17%
Metabolic alkalosis
17%
Hypoalbuminemia
8%
Feeding intolerance
8%
Rapid infusion
8%
Hypophosphatemia
8%
Hypoglycemia
8%
Hypertriglyceridemia
8%
Neutropenia
8%
gastrointestinal bleed
8%
Elevated GGT
8%
Thrombosis
8%
Hyperchloremia
8%
Increased respiratory support
8%
Thrombocytopenia
8%
Hyponatremia
8%
Urinary tract infection
8%
Hypernatremia
8%
Elevated alkaline phosphatase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Smoflipid 20%
Intralipid 20% Reduction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LipidExperimental Treatment1 Intervention
Infusion of drug (Smoflipid) will occur over a 16.5 hour period given once per day for the first two days of study enrollment.
Group II: ControlActive Control1 Intervention
Control patients will receive no experimental drug (ie, usual care)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smoflipid
2015
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,395 Previous Clinical Trials
767,224 Total Patients Enrolled
20 Trials studying Sepsis
7,654 Patients Enrolled for Sepsis
Faheem W Guirgis, MDPrincipal InvestigatorUniversity of Florida
1 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Sepsis
110 Patients Enrolled for Sepsis
~9 spots leftby Nov 2025
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