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

Critical Illness Clinical Trial

Official title:

Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04850456
• Other study ID #: fdpicu-16
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Guoping Lu, Doctor
• Phone: 13788904150
• Email: 13788904150[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Sepsis
• Sepsis, Severe

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The death rate of children	The death rate of children in 28 days after their discharged from PICU	within 28 days after they discharged from PICU
Primary	length of stay in PICU	Time from PICU admission to discharge	up to 28 days
Secondary	CD4+/CD8+	levels of peripheral blood subgroup of T lymphocyte (digital form)	Within 3 to 15 days after the start of treatment
Secondary	C-reactive protein (CRP)	C-reactive protein (digital form)	Within 3 to 15 days after the start of treatment
Secondary	IL-2R	The interleukin-2 receptor (digital form)	Within 3 to 15 days after the start of treatment
Secondary	TNF-alpha	Tumor necrosis factor alpha (digital form)	Within 3 to 15 days after the start of treatment
Secondary	Treg	levels of peripheral blood subgroup of T lymphocyte (digital form)	Within 3 to 15 days after the start of treatment
Secondary	IL-6	The interleukin-6 (digital form)	Within 3 to 15 days after the start of treatment
Secondary	IFN-gamma	Interferon gamma (digital form)	Within 3 to 15 days after the start of treatment
Secondary	Procalcitonin (digital form)	Procalcitonin (digital form)	Within 3 to 15 days after the start of treatment
Secondary	IL-10	The interleukin-10 (digital form)	Within 3 to 15 days after the start of treatment