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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• The death rate of children [Срок оценки: within 28 days after they discharged from PICU]
• length of stay in PICU [Срок оценки: up to 28 days]

Вторичные конечные точки (9)

• CD4+/CD8+ [Срок оценки: Within 3 to 15 days after the start of treatment]
• C-reactive protein (CRP) [Срок оценки: Within 3 to 15 days after the start of treatment]
• IL-2R [Срок оценки: Within 3 to 15 days after the start of treatment]
• TNF-alpha [Срок оценки: Within 3 to 15 days after the start of treatment]
• Treg [Срок оценки: Within 3 to 15 days after the start of treatment]
• IL-6 [Срок оценки: Within 3 to 15 days after the start of treatment]
• IFN-gamma [Срок оценки: Within 3 to 15 days after the start of treatment]
• Procalcitonin (digital form) [Срок оценки: Within 3 to 15 days after the start of treatment]
• IL-10 [Срок оценки: Within 3 to 15 days after the start of treatment]

Критерии участия

Критерии включения

• children hospitalized in PICU of Children's Hospital of Fudan University
• Children With Severe Infection Complicated With Inflammatory Storm

Критерии исключения

• discharge within 48 hours
• patients without informed consent
• incomplete clinical and demographic data

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Children's Hospital of Fudan University — Шанхай
• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT04850456 · fdpicu-16

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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