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NCT04103268 Clinical Trial

Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

Sepsis Clinical Trial

Official title:
Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04103268
Other study ID # IRB-P00031930
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 4, 2020
Est. completion date December 1, 2024

Study information
Verified date November 2023
Source Boston Children's Hospital
Contact Koichi Yuki, MD
Phone 617-355-6225
Email koichi.yuki@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 72
Est. completion date December 1, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers
Gender All
Age group 1 Month to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• sepsis
patients in the ICU with infection called sepsis

Locations
Country Name City State
United States Boston Children's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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