Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness, Sepsis, Severe. Basic parameters: 29 Days — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study
Overview
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.
Primary outcome measures
- The death rate of children [Time frame: within 28 days after they discharged from PICU]
- length of stay in PICU [Time frame: up to 28 days]
Secondary outcome measures (9)
- CD4+/CD8+ [Time frame: Within 3 to 15 days after the start of treatment]
- C-reactive protein (CRP) [Time frame: Within 3 to 15 days after the start of treatment]
- IL-2R [Time frame: Within 3 to 15 days after the start of treatment]
- TNF-alpha [Time frame: Within 3 to 15 days after the start of treatment]
- Treg [Time frame: Within 3 to 15 days after the start of treatment]
- IL-6 [Time frame: Within 3 to 15 days after the start of treatment]
- IFN-gamma [Time frame: Within 3 to 15 days after the start of treatment]
- Procalcitonin (digital form) [Time frame: Within 3 to 15 days after the start of treatment]
- IL-10 [Time frame: Within 3 to 15 days after the start of treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- Children's Hospital of Fudan University — Shanghai
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT04850456 · fdpicu-16