Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- length of stay in PICU
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 29 Days to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
trial group
Human Gamma Globulin
control group
conventional treatment
Outcomes
Primary Outcomes
length of stay in PICU
Time Frame: up to 28 days
Time from PICU admission to discharge
The death rate of children
Time Frame: within 28 days after they discharged from PICU
The death rate of children in 28 days after their discharged from PICU
Secondary Outcomes
- Procalcitonin (digital form)(Within 3 to 15 days after the start of treatment)
- IL-10(Within 3 to 15 days after the start of treatment)
- CD4+/CD8+(Within 3 to 15 days after the start of treatment)
- IL-2R(Within 3 to 15 days after the start of treatment)
- TNF-alpha(Within 3 to 15 days after the start of treatment)
- Treg(Within 3 to 15 days after the start of treatment)
- IFN-gamma(Within 3 to 15 days after the start of treatment)
- C-reactive protein (CRP)(Within 3 to 15 days after the start of treatment)
- IL-6(Within 3 to 15 days after the start of treatment)