Recruiting

Neutrophils in Sepsis

Sponsor:

Boston Children's Hospital

Code:

NCT04103268

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

sepsis

Study Details

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.

Conditions

Sepsis

Study ID

NCT04103268

Start date

Aug 4, 2020

Status verified date

Jan, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Interventions and Outcome Measures

Arms

Sepsis

Control

Interventions

sepsis

patients in the ICU with infection called sepsis

Primary outcome measure

  • neutrophil populations [ Time Frame: up to 1 month ]

Central Contacts and Locations

Central contacts

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Koichi Yuki, MD

617-355-6225koichi.yuki@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-01-07.