Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis

NCT04576819 | Completed

• 2 other identifiers: IRB201903081-N1R01GM133815-01A1
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Shock, Septic

Outcome Measures

Primary Outcomes (1)

• Chronic Critical Illness or Early Death

  CCI defined as admission to ICU \> 14 days total with organ dysfunction, Early death defined as death within 14 days of hospital admission

  14 days from sepsis onset

Study Arms (1)

Sepsis cohort

Inclusion criteria * Patients meeting the Sepsis-3 definition of sepsis or septic shock (the sequential organ failure assessment (SOFA) score will be used for organ failure assessment for Sepsis-3 criteria) * Treatment with an institutional, evidence-based guideline management bundle for sepsis * Within 24 hrs of sepsis recognition Exclusion criteria: * alternative/confounding diagnosis causing shock (e.g., myocardial infarction or pulmonary embolus), * uncontrollable source of sepsis (e.g., irreversible disease state such as unresectable dead bowel), * advanced directives limiting resuscitative efforts, * organ transplant recipient on immunosuppressive agents, * known pregnancy, * inability to obtain informed consent, * HIV/AIDS with CD4 count \< 200, * absolute neutrophil count \< 500

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients meeting the Sepsis-3 definition of sepsis and being treated with institutional evidence-based care bundles.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• Augustin B, Wu D, Black LP, Bertrand A, Sulaiman D, Hopson C, Jacob V, Shavit JA, Hofmaenner DA, Labilloy G, Smith L, Cagmat E, Graim K, Datta S, Reddy ST, Guirgis FW. Multiomic molecular patterns of lipid dysregulation in a subphenotype of sepsis with higher shock incidence and mortality. Crit Care. 2024 Dec 24;28(1):431. doi: 10.1186/s13054-024-05216-3.

  PMID: 39716214 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection for serum, plasma, leukocytes samples for RNA extraction, and PBMC collection for RNA sequence analysis. DNA samples may also be obtained.

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Faheem Guirgis, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 6, 2020
• Study Start: November 20, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)