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Recruiting Observational

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

NCT04850456 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-10-01
Last updated
2026-03-16

Condition(s) studied

Critical IllnessSepsis, Severe

Study 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

Sex
ALL
Min age
29 Days
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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
  • length of stay in PICU — up to 28 days
    Time from PICU admission to discharge

Trial sites (2)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting
Children's Hospital of Fudan University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04850456 on ClinicalTrials.gov ↗ ← All trials in China