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NCT Number: NCT04103268

Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

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.

Recruiting

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Key information

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Koichi Yuki, MD

CONTACT

[email protected]

617-355-6225

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sepsis

Other

patients in the ICU with infection called sepsis

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Koichi Yuki, MD

CONTACT

[email protected]

617-355-6225

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2019
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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