Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis

Recruiting now

Conditions studied: Sepsis, Trauma Injury

In brief

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.

Key facts

Study ID

NCT05110937

Run by

University of Florida

People needed

450

Starts

2022-01-04

Expected to finish

2027-04-01

Last updated by the study team

2025-12-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age ≥18 years
• meets criteria for sepsis/septic shock by Sepsis-3 consensus criteria.

You may not qualify if…

• 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.
• Prisoners.
• Pregnancy.
• 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 it is running

• UF Health at Shands hospital — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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