Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Florida
About this trial
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
This trial accepts healthy volunteersQualifiers
age ≥18 years
meets criteria for sepsis/septic shock by Sepsis-3 consensus criteria.
Disqualifiers
have disease states that predispose to significant immune system dysfunction
known pregnancy
enrollment >96 hours after suspected sepsis onset
pre-hospitalization bedridden performance status (WHO/Zubrod score ≥4)
Trial population
Patients admitted to surgical and trauma intensive care units who screen positive for sepsis and are being treated by our standard-of-care sepsis protocol are candidates for the studies proposed in this proposal. For the purpose of these studies, sepsis will be defined using the new Sepsis-3 criteria. Patients admitted to the surgical and trauma intensive care units who have severe blunt trauma injury and have high risk of in-hospital sepsis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood sampling
Other interventionBlood sampling
Treatment groups
450 Participants
are divided into 3 treatment groupsGroup A: Sepsis1 intervention
Group B: Healthy Controls1 intervention
Group C: Trauma1 intervention
Trial outcomes
Primary outcomes
1
The total number of neutrophils and early myeloid derived suppressor cells will be measured and will be used to determine the magnitude of myelopoiesis dysfunction.
The total number of neutrophils and early Myeloid derived suppressor cells will be measured at sepsis onset and during hospitalization and at 3 and 6 months.
Time frame
6 monthsSponsors and contacts
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University of Florida
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov