NCT05110937 · University of Florida
Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Blood sampling
Blood sampling
Primary outcome measures
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
The total number of neutrophils and early Myeloid derived suppressor cells will be measured at sepsis onset and during hospitalization and at 3 and 6 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- age ≥18 years
- meets criteria for sepsis/septic shock by Sepsis-3 consensus criteria.
Exclusion criteria
- have disease states that predispose to significant immune system dysfunction
- 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.
- known pregnancy
- enrollment \>96 hours after suspected sepsis onset
- pre-hospitalization bedridden performance status (WHO/Zubrod score ≥4)
- subsequent clinical adjudication diagnosis not consistent with sepsis/septic shock by Sepsis-3 criteria.
- Burn injury greater than 20% total body surface area (tBSA) Trauma Participant: Inclusion Criteria
- All adults age ≥ 18 years
- 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
- Patients not expected to survive greater than 48 hours.
- Previous bone marrow transplantation.
- Patients with End Stage Renal Disease.
- Patients with any pre-existing hematological disease.
- Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.
- Known HIV infection with CD4+ count \<200 cells/mm3
- Burn injury greater than 20% tBSA
Where
- Gainesville, Florida
Collaborators
National Institute of General Medical Sciences (NIGMS)
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Dec 26, 2025 · Source of record for eligibility and locations