Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children

Study Overview
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Brief Summary
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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-1β and its receptor antagonists in patients with severe sepsis and septic shock is discussed controversially. To date, the efficacy and safety of IL-1β and its receptor antagonists in children with severe infection is not fully evaluated.

Detailed Description
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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.

Official Title
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Effects of IL-1β and Its Receptor Antagonists in the Treatment of Severe Infection and Inflammatory Storm in Children

Conditions
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Critical Illness, Sepsis, Severe

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 29 days and 18 years old. 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: Notifiable infectious diseases. The researcher believes that he is not suitable to participate in other situations in this study. Participants in other clinical trials in the same period. Discharge within 48 hours

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| trial group<br>anakinra canakinumab | |
| control group<br>conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | The death rate of children in 28 days after their discharged from PICU | within 28 days after they discharged from PICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in PICU | Time from PICU admission to discharge | within 28 days after they discharged from PICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Critical Illness, anakinra, canakinumab, children