SepsisNCT02934997
The Role of Dysfunctional HDL in Sepsis
An observational study of Sepsis and Septic Shock, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Observational study
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 3 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis or septic shock presenting to both sites.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
About this study
Official title: The Role of Dysfunctional HDL in Community and Hospital Acquired Sepsis
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.
Read the detailed description
The long-term goal of this research program is to characterize the antecedents and mediators of morbid long-term outcomes in patients with sepsis. Despite successful early management, sepsis is a disease with a high incidence of chronic critical illness (CCI - intensive care unit stay ≥ 14 days with organ dysfunction) and morbid long-term outcomes (functional dependence or death at 1 year), which occur frequently in early survivors. Both the rapid identification of patients at risk for morbid outcomes and the development of novel therapies are crucial for improving outcomes after sepsis. High density lipoprotein (HDL) defends against sepsis-associated organ injury by: 1) neutralizing bacterial endotoxin, 2) modulating innate cellular immunity and preventing release of inflammatory cytokines, and 3) preventing endothelial cell activation and dysfunction. However, HDL can become dysfunctional (Dys-HDL) in the setting of inflammation, losing protective functions and becoming pro-inflammatory. Our preliminary results demonstrate that Dys-HDL is present in early sepsis and that persistent Dys-HDL elevation (first 48 hours) is associated with adverse outcomes (death, hospice or nursing home care). The overall goal of this proposal is to investigate and fully characterize the role of Dys-HDL in a diverse population of patients with both CA and HA-sepsis. The central hypothesis of this study is that structural and functional changes in HDL during sepsis are associated with the persistent presence of Dys-HDL as well as the inflammation and endothelial dysfunction that lead to acute organ dysfunction, CCI, and morbid long-term outcomes. To test this, we will enroll 160 patients in a two-site, prospective, longitudinal, cohort study.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Observational study
- Keywords
- sepsis, septic shock, cholesterol, high density lipoprotein
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early sepsis-associated organ dysfunction, incidence of chronic critical illness and morbid long-term outcomes after sepsis.
Measured: 1 year
Secondary outcomes (2)
The temporal relationship between Dys-HDL and sepsis and endothelial biomarkers in patients with sepsis.
Measured: 4 days
Explore changes in HDL function from patients with sepsis with rapid recovery versus patients with sepsis who develop CCI versus healthy controls.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start1 Nov 2016
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Faheem Guirgis, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934997
- Sponsor's protocol ID
- IRB201701349-N
- Other IDs
- UFlorida, 1K23GM115690-01, UFJ2016-032
- Status last verified
- Feb 2020
- First submitted
- 12 Oct 2016
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40267485Augustin 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.
PubMed 39716214Black 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.
PubMed 38407817
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dysfunctional HDL in Community and Hospital Acquired Sepsis
- ClinicalTrials.gov ID
- NCT02934997
- Acronym / sponsor ID
- IRB201701349-N
- Conditions
- Sepsis, Septic Shock
- Keywords
- sepsis, septic shock, cholesterol, high density lipoprotein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The long-term goal of this research program is to characterize the antecedents and mediators of morbid long-term outcomes in patients with sepsis. Despite successful early management, sepsis is a disease with a high incidence of chronic critical illness (CCI - intensive care unit stay ≥ 14 days with organ dysfunction) and morbid long-term outcomes (functional dependence or death at 1 year), which occur frequently in early survivors. Both the rapid identification of patients at risk for morbid outcomes and the development of novel therapies are crucial for improving outcomes after sepsis. High density lipoprotein (HDL) defends against sepsis-associated organ injury by: 1) neutralizing bacterial endotoxin, 2) modulating innate cellular immunity and preventing release of inflammatory cytokines, and 3) preventing endothelial cell activation and dysfunction. However, HDL can become dysfunctional (Dys-HDL) in the setting of inflammation, losing protective functions and becoming pro-inflammatory. Our preliminary results demonstrate that Dys-HDL is present in early sepsis and that persistent Dys-HDL elevation (first 48 hours) is associated with adverse outcomes (death, hospice or nursing home care). The overall goal of this proposal is to investigate and fully characterize the role of Dys-HDL in a diverse population of patients with both CA and HA-sepsis. The central hypothesis of this study is that structural and functional changes in HDL during sepsis are associated with the persistent presence of Dys-HDL as well as the inflammation and endothelial dysfunction that lead to acute organ dysfunction, CCI, and morbid long-term outcomes. To test this, we will enroll 160 patients in a two-site, prospective, longitudinal, cohort study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-Acquired Sepsis | – | Other: Observational studyThe 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. |
| Hospital-Acquired Sepsis | – | Other: Observational studyUFH (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis or septic shock presenting to both sites.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study | Other | Community-Acquired Sepsis, Hospital-Acquired Sepsis |
Primary outcome
Early sepsis-associated organ dysfunction, incidence of chronic critical illness and morbid long-term outcomes after sepsis.
Time frame: 1 year
2 secondary outcomes
The temporal relationship between Dys-HDL and sepsis and endothelial biomarkers in patients with sepsis.
Time frame: 4 days
Explore changes in HDL function from patients with sepsis with rapid recovery versus patients with sepsis who develop CCI versus healthy controls.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 40267485Labilloy 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.
- Derived from this study: PubMed 39716214Augustin 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.
- Derived from this study: PubMed 38407817Black 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faheem Guirgis, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early sepsis-associated organ dysfunction, incidence of chronic critical illness and morbid long-term outcomes after sepsis. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934997, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.