SepsisNCT07735741
Immune Dysregulation During Sepsis: A Natural History Cohort
An observational study of Sepsis and Septic Shock, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis-Associated Immune Dysregulation
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Jan 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
INOVA Fairfax Hospital
Falls Church, Virginia, 22042
Chris King, 703-953-7837, Christopher.king@inova.org
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sepsis, Septic Shock, Sepsis-Associated Immune Dysregulation
- Keywords
- SEPSIS
- 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 |
|---|---|---|
| Participants with Sepsis | Sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (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.
The secondary outcomes are to study specific immune targets that may be developed into treatments for sepsis.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Jan 2037 (estimated)
- Study completion31 Jan 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Strich, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735741
- Sponsor's protocol ID
- 10002410
- Other IDs
- 002410-H
- Status last verified
- 27 Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Dysregulation During Sepsis: A Natural History Cohort
- ClinicalTrials.gov ID
- NCT07735741
- Acronym / sponsor ID
- 10002410
- Conditions
- Sepsis, Septic Shock, Sepsis-Associated Immune Dysregulation
- Keywords
- SEPSIS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Jan 2037 (estimated)
- Study completion
- 31 Jan 2037 (estimated)
- First posted
- 30 Jul 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Sepsis | – | –Sepsis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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
- Ability of subject or LAR to understand and the willingness to sign a written informed consent document
Key exclusion criteria (8 listed)
- 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
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
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
The primary outcomes is intended to study how certain immune cells contribute to sepsis pathogenesis.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Jeffrey R Strich, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
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 Septic Shock, run by National Heart, Lung, and Blood Institute (NHLBI) 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey R Strich, M.D. ((301) 496-9320, jeffrey.strich@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.