Treatment of IL-6 and Its Receptor Antagonists in Children's Severe Sepsis.

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04850443

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In severe infective patients who survive the initial inflammatory storm, the immune response often evolves toward a state of immunosuppression, which contributes to increased mortality and severe secondary hospital-acquired infections. However, the role of IL-6 and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. To date, the efficacy and safety of IL-6 and its receptor antagonists in children with severe infection is not fully evaluated.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Sepsis, Severe

Detailed Description

The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded. Patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effects of IL-6 and Its Receptor Antagonists in the Treatment of Children With Severe Infection and Inflammatory Storm

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
trial group tocilizumab siltuximab
control group conventional treatment

Outcome Measures

Primary Outcome Measures

survival rate [within 28 days after they discharged from PICU]
The survival rate of children in 28 days after their discharged from PICU

Secondary Outcome Measures

length of stay in PICU [up to 28 days]
Time from PICU admission to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

29 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1.Children between 29 days and 18 years old. 2.Severe pneumonia and/or sepsis.Patients were included who meet the guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children.

Exclusion Criteria:

1.notifiable infectious diseases. 2.The researcher believes that he is not suitable to participate in other situations in this study. 3.Participants in other clinical trials in the same period. 4. discharge within 48 hours.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT04850443

Other Study ID Numbers:

fdpicu-20

First Posted:

Apr 20, 2021

Last Update Posted:

Jun 15, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Children's Hospital of Fudan University

Critical Illness, Sepsis, children, tocilizumab, siltuximab

Additional relevant MeSH terms:

Sepsis

Critical Illness

Study Results

No Results Posted as of Jun 15, 2022