Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04103268

Enrollment

Registered

2019-09-25

Start date

2020-08-04

Completion date

2026-12-01

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

OTHERsepsis

patients in the ICU with infection called sepsis

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
neutrophil populations	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

Countries

United States

Contacts

Primary ContactKoichi Yuki, MD

koichi.yuki@childrens.harvard.edu617-355-6225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026