Clinical trial NCT04850456: Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
Official title: Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Sepsis, Severe
Keywords: Sepsis
Critical Illness
Inflammatory Storm
Gamma Globulin
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023

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.

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

Primary outcomes:
measure: The death rate of children
timeFrame: within 28 days after they discharged from PICU
measure: length of stay in PICU
timeFrame: up to 28 days
Secondary outcomes:
measure: CD4+/CD8+
timeFrame: Within 3 to 15 days after the start of treatment
measure: C-reactive protein (CRP)
timeFrame: Within 3 to 15 days after the start of treatment
measure: IL-2R
timeFrame: Within 3 to 15 days after the start of treatment
measure: TNF-alpha
timeFrame: Within 3 to 15 days after the start of treatment
measure: Treg
timeFrame: Within 3 to 15 days after the start of treatment
measure: IL-6
timeFrame: Within 3 to 15 days after the start of treatment
measure: IFN-gamma
timeFrame: Within 3 to 15 days after the start of treatment
measure: Procalcitonin (digital form)
timeFrame: Within 3 to 15 days after the start of treatment
measure: IL-10
timeFrame: Within 3 to 15 days after the start of treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References: