RECRUITING

Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology Subtitle: Pathological Myeloid Activation After Sepsis and Trauma

Quick Facts

Study Start:2022-01-04

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05110937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. age ≥18 years 2. meets criteria for sepsis/septic shock by Sepsis-3 consensus 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: 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) 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) 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

Inclusion Criteria

Exclusion Criteria

1. age ≥18 years
2. meets criteria for sepsis/septic shock by Sepsis-3 consensus 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:
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)
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)
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

Contacts and Locations

Study Contact

Jennifer Lanz, MSN

CONTACT

352-273-5497

jennifer.lanz@surgery.ufl.edu

Ruth Davis, BSN

CONTACT

352-273-5897

ruth.davis@surgery.ufl.edu

Principal Investigator

Lyle Moldawer, PhD

PRINCIPAL_INVESTIGATOR

University of Florida

Philip Efron, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Tyler Loftus, MD

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

UF Health at Shands hospital

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Lyle Moldawer, PhD, PRINCIPAL_INVESTIGATOR, University of Florida
Philip Efron, MD, PRINCIPAL_INVESTIGATOR, University of Florida
Tyler Loftus, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-04

Study Completion Date2026-04

Study Record Updates

Study Start Date2022-01-04

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Sepsis
Trauma Injury