Actively Recruiting

Age: 18Years - 100Years
All Genders
Healthy Volunteers
NCT05110937

Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis

Led by University of Florida · Updated on 2025-12-26

450

Participants Needed

1

Research Sites

273 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

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.

CONDITIONS

Official Title

Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis

Who Can Participate

Age: 18Years - 100Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Meets criteria for sepsis or septic shock by Sepsis-3 consensus criteria
  • Adults age 18 years or older with blunt trauma
  • Blunt trauma patients with Injury Severity Score (ISS) 25 or higher
  • Blunt trauma patients with ISS over 15 and either significant blood transfusion, spine injury, or shock on arrival
  • Blunt trauma patients with ISS over 15 and at least two of these: age over 55, chest injury, positive alcohol on arrival, or red blood cell transfusion in first 24 hours
Not Eligible

You will not qualify if you...

  • Diseases causing significant immune system dysfunction
  • Conditions or care goals that prevent recovery after sepsis, including irreversible shock, uncontrollable infection source, futile care, alternative shock diagnoses, low CD4+ count in HIV infection, severe brain injury with Glasgow Coma Score 3
  • Known pregnancy
  • Enrollment more than 96 hours after suspected sepsis onset
  • Pre-hospital bedridden status with WHO/Zubrod score 4 or higher
  • Diagnosis after enrollment not consistent with sepsis/septic shock by Sepsis-3 criteria
  • Burn injury over 20% of total body surface area
  • Patients not expected to survive more than 48 hours
  • Prisoners
  • Previous bone marrow transplantation
  • End Stage Renal Disease
  • Pre-existing blood diseases
  • Advanced care directives limiting resuscitation
  • Known HIV infection with CD4+ count below 200 cells/mm3
  • Burn injury greater than 20% total body surface area

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UF Health at Shands hospital

Gainesville, Florida, United States, 32610

Actively Recruiting

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Research Team

J

Jennifer Lanz, MSN

CONTACT

R

Ruth Davis, BSN

CONTACT

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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