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

Recruiting now

Conditions studied: Critical Illness, Sepsis, Severe

In brief

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.

Key facts

Study ID

NCT04850456

Run by

Children's Hospital of Fudan University

People needed

200

Starts

2024-10-01

Expected to finish

2026-12-31

Last updated by the study team

2026-03-16

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Children's Hospital of Fudan University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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