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NCT Number: NCT04850456

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Sepsis, Severe Systemic Inflammatory Response Syndrome

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. length of stay in PICU

    Time frame: up to 28 days

    Time from PICU admission to discharge

Secondary outcomes

  1. CD4+/CD8+

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

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

  2. C-reactive protein (CRP)

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

    C-reactive protein (digital form)

  3. IL-2R

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

    The interleukin-2 receptor (digital form)

  4. TNF-alpha

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

    Tumor necrosis factor alpha (digital form)

  5. Treg

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

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

  6. IL-6

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

    The interleukin-6 (digital form)

  7. IFN-gamma

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

    Interferon gamma (digital form)

  8. Procalcitonin (digital form)

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

    Procalcitonin (digital form)

  9. IL-10

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

    The interleukin-10 (digital form)

Study contacts

Contact information is provided by the study sponsor or research team.

Guoping Lu, Doctor

CONTACT

[email protected]

13788904150

Yao Wang

CONTACT

[email protected]

+86 13636547582

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2021
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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