Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis

In this research study we want to learn more about the characteristics of neutrophils that are present in the blood and secretions from a breathing tube of patients 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 the lungs 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 and secretions from the breathing tube of patients 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): 75

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: 2 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients from 2-50 years old at Boston Children's Hospital either in an ICU with sepsis or a healthy control coming for a surgical procedure.

Description

Case Inclusion Criteria:

• sepsis patient in the ICU with a breathing tube

Control Inclusion Criteria:

• 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
• Plan to have endotracheal tube for planned procedures.

Exclusion Criteria:

• On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases (oncology patients, patients with transplantation)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis Patients	Other: Sepsis; Sepsis patients in the ICU with a breathing tube
Control Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil characteristics	measure and report β2 integrin expression on neutrophils from blood and tracheal aspirate between sepsis patients and non-sepsis patients in pediatric population	One day

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): September 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026

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 (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: IRB-P00033027

Drug and device information, study documents

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