NCT04103281

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Sep 2020Dec 2026

First Submitted

Initial submission to the registry

September 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

5.8 years

First QC Date

September 23, 2019

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Sepsis Patients

Other: Sepsis

Control Patients

Interventions

SepsisOTHER

Sepsis patients in the ICU with a breathing tube

Sepsis Patients

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • sepsis patient in the ICU with a breathing tube
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Koichi Yuki, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
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

September 1, 2020

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations