SepsisNCT04576819
Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis
An observational study of Sepsis and Shock, Septic, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Shock, Septic
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 1 Apr 2023
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients meeting the Sepsis-3 definition of sepsis and being treated with institutional evidence-based care bundles.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sepsis, Shock, Septic
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days from sepsis onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start20 Nov 2020
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 58 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
- NCT04576819
- Sponsor's protocol ID
- IRB201903081-N
- Other IDs
- 1R01GM133815-01A1
- Status last verified
- Jun 2024
- First submitted
- 25 Sep 2020
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39716214
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis
- ClinicalTrials.gov ID
- NCT04576819
- Acronym / sponsor ID
- IRB201903081-N
- Conditions
- Sepsis, Shock, Septic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 6 Oct 2020 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients meeting the Sepsis-3 definition of sepsis and being treated with institutional evidence-based care bundles.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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 21 Jun 2024.
- 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.
- Individual participant dataSharing planned: No
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Shock, Septic, run by University of Florida at 1 site in United States.
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 3 inclusion and 7 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Chronic Critical Illness or Early Death (time frame: 14 days from sepsis onset). 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 NCT04576819, which also lists 1 linked publication.
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 21 Jun 2024.