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

NCT04821414 | Withdrawn

• 1 other identifier: fdpicu-19
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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-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.

Conditions

Critical Illness; Sepsis, Severe

Keywords

Critical Illness; Sepsis; anakinra; canakinumab; children

Outcome Measures

Primary Outcomes (1)

• survival rate

  The death rate of children in 28 days after their discharged from PICU

  within 28 days after they discharged from PICU

Secondary Outcomes (1)

• length of stay in PICU

  within 28 days after they discharged from PICU

Study Arms (2)

trial group

anakinra canakinumab

control group

conventional treatment

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Critical Illness; Sepsis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06