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Can tracking immune chaos in sepsis reveal new treatment targets?

NCT ID NCT07735741

Knowledge-focused Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

Sepsis happens when the body's immune response spirals out of control, damaging organs and causing about 1 in 5 deaths worldwide. This study follows 500 adults hospitalized with sepsis to track how their immune systems change over time. Researchers will collect blood samples and medical data to understand the role of specific immune cells, with the goal of identifying new ways to treat sepsis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study clarifies how the immune system goes awry in sepsis, it could point toward new treatments that calm the immune response and reduce organ damage.
What could go wrong
This is an observational study, not a treatment trial, so it will not directly test any therapy. The findings may not lead to immediate clinical changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2037

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis Sepsis-associated immune dysregulation Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • INOVA Fairfax Hospital

    Falls Church, Virginia, 22042, United States

More trials for these conditions

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