Expression Profiles of Integrin αDβ2 on Neutrophils in Se... | NCT04103281

Studies
Expression Profiles of Integrin αDβ2 on Neutrophils in Sepsis

NCT04103281

Sponsor

Boston Children's Hospital

Status

Recruiting

Last Update Posted

Mar 17, 2026Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Sepsis

Interventions

Sepsis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Sep 23, 2019

First Submission Date that Met QC Criteria

Sep 24, 2019

First Posted Date

Sep 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepsis Patients			Other: Sepsis
Control Patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sepsis	Other	Sepsis patients in the ICU with a breathing tube	Sepsis Patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Koichi Yuki, MD	Contact	617-355-6225		koichi.yuki@childrens.harvard.edu

Overall Officials

Name	Affiliation	Role
Koichi Yuki, MD	Boston Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Children's Hospital	Recruiting	Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided