Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients meeting the Sepsis-3 definition of sepsis or septic shock
Treatment with an institutional, evidence-based guideline management bundle for sepsis within 24 hrs of sepsis recognition
Sequential organ failure assessment (SOFA) score will be used for organ failure assessment.

Exclusion criteria

a) alternative/confounding diagnosis causing shock (e.g., myocardial infarction or pulmonary embolus)
b) uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel)
c) advanced directives limiting resuscitative efforts
d) organ transplant recipient on immunosuppressive agents
e) known pregnancy
f) inability to obtain informed consent
g) HIV/AIDS with CD4 count < 200, h) absolute neutrophil count < 500. These criteria are justified by numerous prior studies.

Treatment and study plan

Primary outcomes

Chronic Critical Illness or Early Death

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Oct 6, 2020
Registry last updated: Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed