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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: sepsis

• Study Type: Observational
• Enrollment (Estimated): 72

Contacts and Locations

• Study Contact: Name: Koichi Yuki, MD; Phone Number: 617-355-6225; Email: koichi.yuki@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Koichi Yuki, MD; Phone Number: 617-355-6225; Email: koichi.yuki@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis	Other: sepsis; patients in the ICU with infection called sepsis
Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Koichi Yuki, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: IRB-P00031930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No