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Scientists probe immune chaos after sepsis and trauma

NCT ID NCT05110937

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study looks at how severe infections (sepsis) and major injuries change the way the body produces certain immune cells called myeloid cells. Researchers want to understand why these changes can lead to ongoing inflammation and a weakened immune system. The study will follow 450 adults in the hospital and for up to 6 months after, measuring specific cells in their blood. This is an observational study, not a treatment trial, so participants will not receive any experimental therapy.

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 450 people

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

Started

Jan 2022

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients admitted to surgical and trauma intensive care units who screen positive for sepsis and are being treated by our standard-of-care sepsis protocol are candidates for the studies proposed in this proposal. For the purpose of these studies, sepsis will be defined using the new Sepsis-3 criteria. Patients admitted to the surgical and trauma intensive care units who have severe blunt trauma injury and have high risk of in-hospital sepsis.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Sepsis participant: Inclusion Criteria: 1. age ≥18 years 2. meets criteria for sepsis/septic shock by Sepsis-3 consensus criteria. Exclusion Criteria: 1. have disease states that predispose to significant immune system dysfunction 2. have comorbidity burden or goals of care that preclude recovery after sepsis. These criteria include: a. irreversible shock (death \<12 hours) b. uncontrollable surgical source of sepsis c. patients deemed to be futile care or have advanced directives limiting resuscitative efforts d. alternative diagnoses causing shock state (e.g., hemorrhage, myocardial infarction or pulmonary embolus) e. known HIV infection with CD4+ count \<200 cells/mm3 g. severe traumatic brain injury with unencumbered assessment of GCS equaling 3 on admission to the intensive care unit. 3. known pregnancy 4. enrollment \>96 hours after suspected sepsis onset 5. pre-hospitalization bedridden performance status (WHO/Zubrod score ≥4) 6. subsequent clinical adjudication diagnosis not consistent with sepsis/septic shock by Sepsis-3 criteria. 7. Burn injury greater than 20% total body surface area (tBSA) Trauma Participant: Inclusion Criteria 1. All adults age ≥ 18 years 2. Blunt trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \> 15 and one of the following: i. \> 4 units of PRBC or \>3 units of whole blood or \>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \> 2 spine iii. Shock on arrival (Systolic blood pressure (SBP) \< 90) OR c. ISS \> 15 and two of the following: i. Age \> 55 ii. AIS \> 2 chest iii. +ETOH (ethyl alcohol) on arrival iv. Any red blood cell transfusion in first 24 hours Exclusion Criteria 1. Patients not expected to survive greater than 48 hours. 2. Prisoners. 3. Pregnancy. 4. Previous bone marrow transplantation. 5. Patients with End Stage Renal Disease. 6. Patients with any pre-existing hematological disease. 7. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts. 8. Known HIV infection with CD4+ count \<200 cells/mm3 9. Burn injury greater than 20% tBSA

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • UF Health at Shands hospital

    RECRUITING

    Gainesville, Florida, 32610, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.