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Clinical Trials/NCT04103268
NCT04103268
Recruiting
Not Applicable

Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

Boston Children's Hospital1 site in 1 country72 target enrollmentAugust 4, 2020
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Boston Children's Hospital
Enrollment
72
Locations
1
Primary Endpoint
neutrophil populations
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

In this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in organs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood of children with sepsis so that they can work to develop therapies to prevent these cells from being harmful.

Registry
clinicaltrials.gov
Start Date
August 4, 2020
End Date
December 1, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Koichi Yuki

Cardiac Anesthesiologist

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients will be eligible for enrollment as septic patients if they
  • Are \< 18 years old
  • Meet the definition of sepsis described in the study design section above. Patients will be eligible for enrollment as control patients if they
  • Are \< 18 years old
  • Are scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure.

Exclusion Criteria

  • Patients will be ineligible for enrollment in either control or sepsis group if any of the followings is present or anticipated
  • Congenital cardiac disease
  • On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases

Outcomes

Primary Outcomes

neutrophil populations

Time Frame: up to 1 month

compare gene expression in neutrophils between sepsis patients and non-sepsis patients in pediatric population to report unregulated and down regulated genes

Study Sites (1)

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