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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04850456
Enrollment
200
Registered
2021-04-20
Start date
2024-10-01
Completion date
2026-12-31
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Sepsis, Severe

Keywords

Sepsis, Critical Illness, Inflammatory Storm, Gamma Globulin

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.

Interventions

None listed

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Days to 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

Design outcomes

Primary

MeasureTime frameDescription
length of stay in PICUup to 28 daysTime from PICU admission to discharge
The death rate of childrenwithin 28 days after they discharged from PICUThe death rate of children in 28 days after their discharged from PICU

Secondary

MeasureTime frameDescription
IL-6Within 3 to 15 days after the start of treatmentThe interleukin-6 (digital form)
IFN-gammaWithin 3 to 15 days after the start of treatmentInterferon gamma (digital form)
CD4+/CD8+Within 3 to 15 days after the start of treatmentlevels of peripheral blood subgroup of T lymphocyte (digital form)
C-reactive protein (CRP)Within 3 to 15 days after the start of treatmentC-reactive protein (digital form)
IL-2RWithin 3 to 15 days after the start of treatmentThe interleukin-2 receptor (digital form)
TNF-alphaWithin 3 to 15 days after the start of treatmentTumor necrosis factor alpha (digital form)
IL-10Within 3 to 15 days after the start of treatmentThe interleukin-10 (digital form)
Procalcitonin (digital form)Within 3 to 15 days after the start of treatmentProcalcitonin (digital form)
TregWithin 3 to 15 days after the start of treatmentlevels of peripheral blood subgroup of T lymphocyte (digital form)

Countries

China

Contacts

CONTACTGuoping Lu, Doctor
13788904150@163.com13788904150
CONTACTYao Wang
y_wang@fudan.edu.cn+86 13636547582

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026