Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm

NCT04850456 | Recruiting

• 1 other identifier: fdpicu-16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.

Conditions

Critical Illness; Sepsis, Severe

Keywords

Sepsis; Critical Illness; Inflammatory Storm; Gamma Globulin

Outcome Measures

Primary Outcomes (2)

• The death rate of children

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

  within 28 days after they discharged from PICU

• length of stay in PICU

  Time from PICU admission to discharge

  up to 28 days

Secondary Outcomes (9)

• CD4+/CD8+

  Within 3 to 15 days after the start of treatment

• C-reactive protein (CRP)

  Within 3 to 15 days after the start of treatment

• IL-2R

  Within 3 to 15 days after the start of treatment

• TNF-alpha

  Within 3 to 15 days after the start of treatment

• Treg

  Within 3 to 15 days after the start of treatment

Study Arms (2)

trial group

Human Gamma Globulin

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 hospitalized in PICU of Children's Hospital of Fudan University
• Children With Severe Infection Complicated With Inflammatory Storm

You may not qualify if:

• discharge within 48 hours
• patients without informed consent
• incomplete clinical and demographic data

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (2)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, 201102, China

RECRUITING

MeSH Terms

Conditions

Critical Illness; Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guoping Lu, Doctor

CONTACT

13788904150; 13788904150@163.com

Yao Wang

CONTACT

+86 13636547582; y_wang@fudan.edu.cn

Study Design

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

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 20, 2021
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CN (2)