Immune Dysregulation During Sepsis: A Natural History Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sepsis, Septic Shock, Sepsis-Associated Immune Dysregulation. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Background: Sepsis is an illness that occurs when the body s immune system runs out of control. This can damage organs. Sepsis causes an estimated 1 in 5 deaths worldwide. In this natural history study, researchers want to learn more about how the immune system changes during sepsis. They hope this knowledge will help them find better ways to treat sepsis. Objective: To understand how sepsis affects the body over time. Eligibility People aged 18 years and older admitted to INOVA Fairfax Hospital in Virginia and who have sepsis. Design: Researchers will collect data from participants medical records. Participants will have blood drawn at least 5 times while they are in the hospital. Blood may be collected for up to 30 days, if they remain in the hospital that long. The blood will be taken from access lines that are already in place. Some blood draws will be optional. Participants may opt to have up to 3 tests of their heart function while they are in the hospital. Some participants may have a sample of fluid collected from their lungs. Participants will have a follow-up visit about 90 days after they join the study. This visit will be by phone call if they have left the hospital. They will fill out a questionnaire. They will answer questions about their health and how they feel. The call will last about 30 minutes....
Detailed description
Study Description:
This is a natural history study intended to allow the characterization of neutrophil biology and other contributors to the pathogenesis along with short-term outcomes of patients hospitalized with sepsis. Patients admitted to INOVA Fairfax Hospital with sepsis will be enrolled, undergo clinical evaluation, clinical data capture, and will have blood drawn that will be processed and analyzed at the NIH.
Objectives:
The aim of this natural history/observational study is to develop a cohort of patients admitted to the hospital with sepsis who can be followed longitudinally to achieve the following:
Primary objectives:
To investigate the contribution of neutrophils and neutrophil subsets including low density neutrophils to the dysregulated immune response that occurs during the acute phase of sepsis.
Secondary objective:
-To characterize spleen tyrosine kinase expression across immune cells and correlate with soluble biomarkers, cellular phenotypes and gene expression to determine mechanistic pathways that may be amenable to host-direct therapies.
Exploratory:
-To identify novel cellular and soluble phenotypes using multiomic and functional datasets and correlate them with clinical sepsis phenotypes, mortality, and cardiac dysfunction to inform sepsis clinical trajectory and novel therapeutic targets.
Endpoints:
Primary Endpoint:
Changes in the frequency, activation and functional status of neutrophils and neutrophil subsets including low density neutrophils during the acute phase of sepsis and their association with in hospital mortality.
Secondary Endpoints:
-Changes in spleen tyrosine kinase expression across immune cells and its correlation with soluble biomarkers, cellular phenotypes and gene expression and their association with in hospital mortality.
Exploratory:
-Identification of novel cellular and soluble immunological signatures of immune dysregulation during sepsis and their association with cardiac dysfunction, disease severity, and in hospital mortality.
Primary outcome measures
- To investigate the contribution of neutrophils and neutrophil subsets including low density neutrophils to the dysregulated immune response that occurs during the acute phase of sepsis. [Time frame: 10 years]
Secondary outcome measures (1)
- To characterize spleen tyrosine kinase expression across immune cells and correlate with soluble biomarkers, cellular phenotypes and gene expression to determine mechanistic pathways that may be amenable to host-direct therapies. [Time frame: 10 years]
Eligibility criteria
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age >= 18 years old
- Admitted to INOVA Fairfax Hospital
- Meets sepsis-3 definition of sepsis in the last 48 hours
- Suspected infection
- Evidence of organ dysfunction (SOFA score >= 2)
- Ability of subject or LAR to understand and the willingness to sign a written informed consent document
Exclusion criteria
Any individual who meets any of the following criteria will be excluded from participation in this study:
- Hemoglobin < 7 microgram/dL at the time of enrollment
- Hemoglobin <10 microgram/dL in patients with known coronary artery disease or active EKG changes consistent with acute ischemia
- Currently receiving infusion of epinephrine; or dopamine at an infusion rate of > 2.5
microgram/kg/min, norepinephrine of > 20 mircogram/min, or vasopressin > 0.04 units/min
- Neutropenia (absolute neutrophil count less than 1000 cells/microliter)
- Baseline cognitive impairment
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- INOVA Fairfax Hospital — Falls Church
Identifiers
NCT: NCT07735741 · 10002410 · 002410-H