Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

NCT ID: NCT04103268

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis

sepsis

Intervention Type OTHER

patients in the ICU with infection called sepsis

Control

No interventions assigned to this group

Interventions

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sepsis

patients in the ICU with infection called sepsis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* Congenital cardiac disease
* On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Koichi Yuki

Cardiac Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koichi Yuki, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Koichi Yuki, MD

Role: CONTACT

617-355-6225

Facility Contacts

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Koichi Yuki, MD

Role: primary

617-355-6225

References

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Alhamdan F, Gianoli S, Yuki K, Koutsogiannaki S. Single-cell analysis of B cell dysregulation in pediatric sepsis stratified by disease severity. Sci Rep. 2025 Dec 31. doi: 10.1038/s41598-025-34126-9. Online ahead of print.

Reference Type DERIVED
PMID: 41476192 (View on PubMed)

Other Identifiers

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IRB-P00031930

Identifier Type: -

Identifier Source: org_study_id

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