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Recruiting NCT04103268

Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

Observational Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sepsis.
Who it may be relevant to
Registry conditions: Sepsis. Basic parameters: 1 months — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other sepsis
    patients in the ICU with infection called sepsis

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Publications

  • 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
  • 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

Identifiers

NCT: NCT04103268 · IRB-P00031930

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗