Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis

Launched by UNIVERSITY OF FLORIDA · Oct 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system responds in patients with sepsis, a serious condition often caused by infection that can lead to organ failure. Researchers want to understand why certain white blood cells, called myeloid-derived suppressor cells, increase in number during sepsis and how this affects inflammation and the body’s ability to fight infections. By learning more about these processes, the goal is to improve treatment for patients who experience sepsis, especially those who have had trauma injuries.

To participate in this trial, you need to be at least 18 years old and meet specific criteria for having sepsis or severe trauma. For example, if you have been diagnosed with sepsis according to established guidelines, or if you have experienced serious trauma with certain injury scores, you may be eligible. Participants will undergo assessments to help researchers gather important information about their immune response during treatment. It's important to note that there are certain conditions that could prevent someone from joining the study, such as having advanced diseases or being pregnant. If you think you might qualify or want to learn more, discussing it with your healthcare provider could be a great next step.

Gender

ALL

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