Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05110937

Conditions

Sepsis

Trauma Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Blood sampling

Study Details

Brief summary:

Adverse outcomes in surgical sepsis patients are secondary to dysregulated emergency myelopoiesis, and expansion of myeloid-derived suppressor cells. Here we propose to determine the underlying mechanisms behind the increased expansion of these leukocyte populations and the underlying mechanisms that drive inflammation and immune suppression.

Conditions

Sepsis

Trauma Injury

Study ID

NCT05110937

Start date

Jan 4, 2022

Status verified date

Dec, 2025

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Sepsis

Blood collection: Blood will be collected from patient at day 4, day 7, day 14-21 and at 3 and 6 months.

Healthy Controls

Blood Collection.

The healthy volunteer participants will donate a blood sample. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.

Trauma

Blood collection: Blood will be collected from patient at day 4, day 7, day 14-21 and at 3 and 6 months.

Interventions

Blood sampling

Blood sampling

Primary outcome measure

  • The total number of neutrophils and early myeloid derived suppressor cells will be measured and will be used to determine the magnitude of myelopoiesis dysfunction. [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

UF Health at Shands hospital

Recruiting

Gainesville, Florida, United States, 32610

Contacts

More Information

Sponsor

University of Florida

Last update posted

Aug 19, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-19.