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

Recruiting

• Conditions: Critical Illness; Sepsis, Severe

• Registration Number: NCT04850456
• Lead Sponsor: Children's Hospital of Fudan University

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.

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 Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-20
• Study Start: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
length of stay in PICU	up to 28 days	Time from PICU admission to discharge
The death rate of children	within 28 days after they discharged from PICU	The death rate of children in 28 days after their discharged from PICU

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China