NCT05110937 Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis
| NCT ID | NCT05110937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2022-01-04 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2022-01-04 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Lyle Moldawer, PhD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT05110937 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05110937 currently recruiting?
Yes, NCT05110937 is actively recruiting participants. Contact the research team at jennifer.lanz@surgery.ufl.edu for enrollment information.
Where is the NCT05110937 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT05110937 clinical trial?
NCT05110937 is sponsored by University of Florida. The principal investigator is Lyle Moldawer, PhD at University of Florida. The trial plans to enroll 450 participants.