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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

LIPIDS-P Trial Summary

This trial will study whether Smoflipid is safe and effective at raising cholesterol levels in septic patients with moderate organ dysfunction. Secondary outcomes include measures of organ dysfunction, mortality, and biological activity.

Eligible Conditions
  • Sepsis
  • Septic Shock

LIPIDS-P Trial 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

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

LIPIDS-P 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
1,340 Previous Clinical Trials
715,589 Total Patients Enrolled
20 Trials studying Sepsis
7,679 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
UF Health Jacksonville North campus
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
BMJ OpenJournal
Lipid Intensive Drug Therapy for Sepsis Pilot (LIPIDS-P): Phase I/II Clinical Trial Protocol of Lipid Emulsion Therapy for Stabilising Cholesterol Levels in Sepsis and Septic Shock
Guirgis, Faheem W, Lauren Page Black, Martin Daniel Rosenthal, Morgan Henson, Jason Ferreira, Christiaan Leeuwenburgh, Colleen Kalynych, et al.. 2019. “Lipid Intensive Drug Therapy for Sepsis Pilot (LIPIDS-P): Phase I/II Clinical Trial Protocol of Lipid Emulsion Therapy for Stabilising Cholesterol Levels in Sepsis and Septic Shock”. BMJ Open. BMJ. doi:10.1136/bmjopen-2019-029348.
Journal of the American College of Emergency Physicians OpenJournal
Lipid Intensive Drug Therapy for Sepsis Pilot: A Bayesian Phase I Clinical Trial
Guirgis, Faheem W., Lauren Page Black, Elizabeth DeVos, Morgan Henson, Jason Ferreira, Taylor Miller, Martin Rosenthal, et al.. 2020. “Lipid Intensive Drug Therapy for Sepsis Pilot: A Bayesian Phase I Clinical Trial”. Journal of the American College of Emergency Physicians Open. Wiley. doi:10.1002/emp2.12237.
clinicaltrials.govStudy
LIPIDS-P Trial Phase I/II
2018. "LIPIDS-P Trial Phase I/II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03405870.
~10 spots leftby Apr 2025
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