Actively Recruiting
Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology Subtitle: Pathological Myeloid Activation After Sepsis and Trauma
Led by University of Florida · Updated on 2025-12-26
450
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how surgical sepsis leads to poor outcomes like death and reduced quality of life due to abnormal immune cell behavior, specifically focusing on the expansion of myeloid-derived suppressor cells (MDSCs). This study aims to understand the mechanisms behind this immune dysfunction, including how epigenetic changes in bone marrow cells contribute to ongoing inflammation and immune suppression after sepsis. The investigation also explores how these changes compare to other chronic conditions such as cancer and autoimmune disease. This observational study follows patients who experience surgical sepsis and those who suffer severe blunt trauma, collecting blood samples at multiple time points: days 4, 7, 14-21, and at 3 and 6 months. Healthy volunteers also provide blood samples for comparison. The study examines how MDSCs expand over time and their role in suppressing immune function, using advanced methods to analyze immune cells' behavior and genetic changes. Participants will provide blood samples during scheduled visits across several months, allowing researchers to measure immune cell counts and functions. The primary outcome involves measuring the number of neutrophils and early MDSCs at six months to assess immune dysfunction severity. The study includes detailed immune assessments and follows patients longitudinally to understand the progression of immune changes and their impact on recovery after sepsis or trauma.
CONDITIONS
Brief Title
Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Meets Sepsis-3 criteria for sepsis or septic shock (for sepsis participants)
- Adults age 18 years or older with blunt trauma meeting specific injury severity and transfusion criteria (for trauma participants)
- Healthy volunteers willing to donate a blood sample
You will not qualify if you...
- Disease states causing significant immune system dysfunction
- Comorbidities or care goals that prevent recovery after sepsis, including irreversible shock, uncontrollable sepsis source, or futile care
- Alternative shock causes like hemorrhage, heart attack, or pulmonary embolism
- Known HIV infection with CD4+ count less than 200 cells/mm3
- Severe traumatic brain injury with Glasgow Coma Scale of 3 on ICU admission
- Known pregnancy
- Enrollment more than 96 hours after suspected sepsis onset
- Bedridden status before hospitalization (WHO/Zubrod score 4 or higher)
- Diagnosis not consistent with sepsis by Sepsis-3 criteria
- Burn injury exceeding 20% total body surface area
- Patients not expected to survive more than 48 hours (trauma participants)
- Prisoners
- Previous bone marrow transplantation
- End Stage Renal Disease
- Pre-existing hematological diseases
- Advanced directives limiting resuscitative efforts or deemed futile care (trauma participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 months
Participants have blood samples collected to observe the expansion of myeloid-derived suppressor cells and study dysfunctional myelopoiesis over time.
5 visits for blood collection at day 4, day 7, day 14-21, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
UF Health at Shands hospital
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
J
Jennifer Lanz, MSN
R
Ruth Davis, BSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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