An observational study in Sepsis, Septic Shock and Sepsis-Associated Immune Dysregulation, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational
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.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 500 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,143 studies on the registry; 71 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population consists of up to 500 adults admitted to INOVA Fairfax Hospital with community-onset or hospital-onset sepsis. Eligible participants must be 18 years of age or older, meet the Sepsis-3 definition of sepsis within the last 48 hours, have suspected infection, and show evidence of organ dysfunction (SOFA score >=2). Participants are enrolled during inpatient hospitalization and followed longitudinally for up to 90 days from enrollment or until hospital discharge if hospitalization lasts longer than 90 days.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Meets sepsis-3 definition of sepsis in the last 48 hours
EXCLUSION CRITERIA:
Any individual who meets any of the following criteria will be excluded from participation in this study:
microgram/kg/min, norepinephrine of > 20 mircogram/min, or vasopressin > 0.04 units/min
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sepsis
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.
The primary outcomes is intended to study how certain immune cells contribute to sepsis pathogenesis.
Time frame: 10 years
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.
The secondary outcomes are to study specific immune targets that may be developed into treatments for sepsis.
Time frame: 10 years
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2037, 120 months later.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 120 months is above that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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