Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis

Completed

• Conditions: Sepsis; Shock, Septic

• Registration Number: NCT04576819
• Lead Sponsor: University of Florida

Brief Summary

Lipids and lipoproteins (cholesterol and lipid metabolites) are present in sepsis and are highly biologically active regulators of inflammation, but currently the changes in lipid and lipoprotein homeostasis during sepsis are not well understood. This project will investigate the changes in lipid and lipoprotein function, oxidation, metabolites, and changes in gene expression to further our understanding of dysregulated lipid and lipoprotein metabolism in sepsis. We will analyze a bank of samples and make associations with important clinical outcomes (early death, chronic critical illness and sepsis recidivism) as supported by our published work, and will confirm our findings in a small prospective cohort of sepsis patients.

Detailed Description

This study will use biobanked samples from a diverse cohort of 165 sepsis patients (UF Jacksonville and UF Gainesville) and will confirm findings in a small prospective cohort of 50 patients. The following will be tested in patient samples:

Aim 1: Test and compare HDL and LDL function (oxidation/transport) in sepsis patients by clinical outcomes of rapid recovery, early death, CCI, and sepsis recidivism.

Aim 2: Determine the changes in lipid homeostasis and patterns of inflammation that occur in sepsis patients by outcome.

Aim 3: Characterize cholesterol \& lipoprotein-specific metabolic gene expression in whole blood leukocytes and peripheral blood mononuclear cells from sepsis patients.

Study Timeline

• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Study Start: 2020-11-20
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic Critical Illness or Early Death	14 days from sepsis onset	CCI defined as admission to ICU \> 14 days total with organ dysfunction, Early death defined as death within 14 days of hospital admission

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States