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Completed Phase 1Phase 2 Interventional Results available

LIPIDS-P Trial Phase I/II Trial

ClinicalTrials.gov ID: NCT03405870

Public ClinicalTrials.gov record NCT03405870. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The LIPid Intensive Drug Therapy for Sepsis ¬Pilot (LIPIDS-P) Phase I/II Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT03405870
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
University of Florida
Other
Enrollment
59 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 17, 2018 (Actual)
Primary completion
Apr 26, 2023 (Actual)
Completion
Apr 26, 2023 (Actual)
Last update posted
Aug 11, 2025

2018 – 2023

United States locations

U.S. sites
3
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Department of Emergency Medicine, UF Health Gainesville Florida 32610 —
UF Health Emergency Medicine Gainesville Florida 32610 —
UF Health Jacksonville North campus Jacksonville Florida 32218 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03405870, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03405870 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →