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

Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Sepsis, Severe

Detailed Description

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 gamma globulin therapy in patients with severe infection including sepsis and septic shock is discussed controversially. We intend to retrospectively analyze the efficacy and application evaluation of gamma globulin in severely infected children hospitalized in the intensive care unit. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. It is expected to provide evaluation basis for clinicians to formulate treatment plans and clinical pharmacists for special comments on the clinical use of gamma globulin.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Guoping Lu, Doctor; Phone Number: 13788904150; Email: 13788904150@163.com
• Study Contact Backup: Name: Yao Wang; Phone Number: +86 13636547582; Email: y_wang@fudan.edu.cn

Study Locations

• China
  • Shanghai, China, 201102
    • Recruiting
    • Children's Hospital of Fudan University
    • Contact: Guoping Lu; Phone Number: +86 18017590817; Email: 13788904150@163.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Guoping Lu, MD; Phone Number: +86 18017590817; Email: 13788904150@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
control group; conventional treatment
trial group; Human Gamma Globulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay in PICU	Time from PICU admission to discharge	up to 28 days
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4+/CD8+	levels of peripheral blood subgroup of T lymphocyte (digital form)	Within 3 to 15 days after the start of treatment
C-reactive protein (CRP)	C-reactive protein (digital form)	Within 3 to 15 days after the start of treatment
IL-2R	The interleukin-2 receptor (digital form)	Within 3 to 15 days after the start of treatment
TNF-alpha	Tumor necrosis factor alpha (digital form)	Within 3 to 15 days after the start of treatment
Treg	levels of peripheral blood subgroup of T lymphocyte (digital form)	Within 3 to 15 days after the start of treatment
IL-6	The interleukin-6 (digital form)	Within 3 to 15 days after the start of treatment
IFN-gamma	Interferon gamma (digital form)	Within 3 to 15 days after the start of treatment
Procalcitonin (digital form)	Procalcitonin (digital form)	Within 3 to 15 days after the start of treatment
IL-10	The interleukin-10 (digital form)	Within 3 to 15 days after the start of treatment

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis; Critical Illness; Inflammatory Storm; Gamma Globulin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Critical Illness; Sepsis
• Other Study ID Numbers: fdpicu-16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No