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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-18
SponsorChildren's Hospital of Fudan University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

children hospitalized in PICU of Children's Hospital of Fudan University

Children With Severe Infection Complicated With Inflammatory Storm

Disqualifiers

discharge within 48 hours

patients without informed consent

incomplete clinical and demographic data

Trial population

All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: trial group
Group B: control group

Trial outcomes

Primary outcomes

1

The death rate of children

The death rate of children in 28 days after their discharged from PICU

Time frame
within 28 days after they discharged from PICU
2

length of stay in PICU

Time from PICU admission to discharge

Time frame
up to 28 days

Secondary outcomes

1

CD4+/CD8+

levels of peripheral blood subgroup of T lymphocyte (digital form)

Time frame
Within 3 to 15 days after the start of treatment
2

C-reactive protein (CRP)

C-reactive protein (digital form)

Time frame
Within 3 to 15 days after the start of treatment
3

IL-2R

The interleukin-2 receptor (digital form)

Time frame
Within 3 to 15 days after the start of treatment
4

TNF-alpha

Tumor necrosis factor alpha (digital form)

Time frame
Within 3 to 15 days after the start of treatment

Other outcomes

Sponsors and contacts

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