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Recruiting NCT04850456

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

Trial Parameters

Condition Critical Illness
Sponsor Children's Hospital of Fudan University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 29 Days
Max Age 18 Years
Start Date 2024-10-01
Completion 2026-12-31

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.

Eligibility Criteria

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

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