The Role of Dysfunctional HDL in Sepsis

NCT02934997 | Completed

• 4 other identifiers: IRB201701349-NUFlorida1K23GM115690-01UFJ2016-032
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the role of dysfunctional high density lipoprotein (Dys-HDL) in predicting or mediating progression to chronic critical illness or morbid long-term outcomes in patients being treated for community-acquired or hospital-acquired sepsis.

Conditions

Sepsis; Septic Shock

Keywords

sepsis; septic shock; cholesterol; high density lipoprotein

Outcome Measures

Primary Outcomes (1)

• Early sepsis-associated organ dysfunction, incidence of chronic critical illness and morbid long-term outcomes after sepsis.

  1 year

Secondary Outcomes (2)

• The temporal relationship between Dys-HDL and sepsis and endothelial biomarkers in patients with sepsis.

  4 days

• Explore changes in HDL function from patients with sepsis with rapid recovery versus patients with sepsis who develop CCI versus healthy controls.

  90 days

Study Arms (2)

Community-Acquired Sepsis

The Adult ED at UF JAX is a high volume, high acuity ED which treats approximately 90,000 patients per year. All CA-sepsis patients will be recruited from the UF JAX ED. Patients meeting the recently updated definition of sepsis (suspected or confirmed infection plus ≥ 2 SOFA points) OR septic shock (hypotension not responsive to 30 mL/kg IV fluids, vasopressor requirement, and lactate ≥ 2) and being treated with an institutional, evidence-based guideline (EBG) management bundle for sepsis within 24 hours presenting to the UF Health Jacksonville Emergency Department (ED) will be approached for enrollment.

Other: Observational study

Hospital-Acquired Sepsis

UFH (Gainesville) is a Level 1 Trauma Center and surgical tertiary care center with 24 trauma intensive care unit (ICU) and 24 surgery ICU beds and are the primary ICUs for almost every surgical patient in the hospital and the location for recruitment for Project #1 of the Sepsis P50. Patients meeting the recently updated definition of sepsis (suspected or confirmed infection plus ≥ 2 SOFA points) OR septic shock (hypotension not responsive to 30 mL/kg IV fluids, vasopressor requirement, and lactate ≥ 2) and being treated with an institutional, evidence-based guideline (EBG) management bundle for sepsis within 24 hours in the UFH Surgical ICU will be approached for enrollment.

Other: Observational study

Interventions

Observational study OTHER

Community-Acquired Sepsis; Hospital-Acquired Sepsis

Eligibility Criteria

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

Study Population

Patients with sepsis or septic shock presenting to both sites.

You may qualify if:

• patients meeting the recently updated definition of sepsis (suspected or confirmed infection plus ≥ 2 SOFA points) OR septic shock (hypotension not responsive to 30 mL/kg IV fluids, vasopressor requirement, and lactate ≥ 2)23 and being treated with an institutional, evidence-based guideline (EBG) management bundle for sepsis within 24 hours which has been adopted at both sites.

You may not qualify if:

• significant traumatic brain injury (evidence of neurologic injury on CT scan and a GCS \<8)
• refractory shock (likely death within 12 hours)
• 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)
• patients deemed futile care or have advanced directives limiting resuscitative efforts
• severe CHF (NY Heart Association Class IV)
• Child-Pugh Class B or C liver disease
• HIV/AIDS causing severe immunocompromise
• organ transplant recipient on immunosuppressive agents
• known pregnancy
• inability to obtain informed consent
• diagnosed disorders of lipid metabolism.

Sponsors & Collaborators

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

Related Publications (3)

• Labilloy G, Tanaka S, Black LP, Augustin B, Hopson C, Bethencourt J, Wu D, Sulaiman D, Bertrand A, Salomao R, Graim K, Datta S, Reddy S, Guirgis FW, Hofmaenner DA. IDENTIFYING A SEPSIS SUBPHENOTYPE CHARACTERIZED BY DYSREGULATED LIPOPROTEIN METABOLISM USING A SIMPLIFIED CLINICAL DATA ALGORITHM. Shock. 2025 Aug 1;64(2):218-225. doi: 10.1097/SHK.0000000000002605. Epub 2025 Apr 23.

  PMID: 40267485 DERIVED

• 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

• Black LP, Hopson C, Barker G, Munson T, Henson M, Bertrand A, Daly-Crews K, Reddy ST, Guirgis FW. TRENDS IN CHOLESTEROL AND LIPOPROTEINS ARE ASSOCIATED WITH ACUTE RESPIRATORY DISTRESS SYNDROME INCIDENCE AND DEATH AMONG SEPSIS PATIENTS. Shock. 2024 Feb 1;61(2):260-265. doi: 10.1097/SHK.0000000000002295. Epub 2023 Dec 28.

  PMID: 38407817 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples of Serum and Plasma will be drawn and retained for several clinically relevant biomarkers as well as future testing.

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

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: October 12, 2016
• First Posted: October 17, 2016
• Study Start: November 1, 2016
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: February 24, 2020

Record last verified: 2020-02