Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

NCT04103268 | Recruiting

• 1 other identifier: IRB-P00031930
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• neutrophil populations

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

  up to 1 month

Study Arms (2)

Sepsis

Other: sepsis

Control

Interventions

sepsis OTHER

patients in the ICU with infection called sepsis

Sepsis

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

We will enroll pediatric patients with sepsis in an ICU at Boston Children's Hospital and patients without sepsis presenting for an elective surgical procedure at Boston Children's Hospital.

You may qualify if:

• 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.

You may not qualify if:

• Congenital cardiac disease
• On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (2)

• Alhamdan F, Sin YC, Malm E, Van Pelt H, Kim S, Higgins L, Chen Y, Yuki K. Plasma Proteomic Signatures of Pediatric Sepsis Reveal Persistent Inflammation and Phase-Specific Biomarkers. FASEB Bioadv. 2026 Mar 9;8(3):e70098. doi: 10.1096/fba.2026-00006. eCollection 2026 Mar.

  PMID: 41815387 DERIVED

• 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;16(1):3987. doi: 10.1038/s41598-025-34126-9.

  PMID: 41476192 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Koichi Yuki, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koichi Yuki, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Anesthesiologist

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: August 4, 2020
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)