RecruitingNCT05692011

AN69ST Verse PS in CBP in Septic Children

The Effects of a AN69ST Membrane and Polysulphone Membrane on Septic Children With Continuous Blood Purification

Sponsor

Children's Hospital of Fudan University

Enrollment

80 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

Sepsis

Summary

In septic shock, dysregulated host responses to pathogens lead to cytokine storms that damage host tissues and organs, further contributing to the development of organ dysfunction and increased mortality. For sepsis, blood purification can remove inflammatory factors in sepsis by filtration or adsorption, so as to achieve the purpose of reducing inflammatory mediators in the body. However, there are few prospective randomized controlled studies in children. Therefore, this study intends to compare the efficacy and prognosis of different membrane on children with sepsis through a perspective cohort study, so as to provide a corresponding basis for the treatment of children with sepsis blood purification.

Eligibility

Min Age: 29 DaysMax Age: 28 Years

Inclusion Criteria4

Meet the 2005 diagnostic criteria for sepsis
Age 29 days - 18 years old
Sepsis-induced dysfunction of more than one organ or abnormal tissue perfusion, or septic shock
Diagnosis < 48 hours

Exclusion Criteria16

Inability to obtain an informed consent from the subject, family member or an authorized surrogate
Subject has end-stage renal disease and requires chronic dialysis
There is clinical support for non-septic shock
Subject has had chest compressions as part of cardiopulmonary resuscitation this hospitalization without immediate return to communicative state
Subject has uncontrolled hemorrhage
Subject has immunodeficiency diseases
Subject has received chemoradiotherapy or immunosuppressive therapy in the 14 days before enrollment
HIV infection in association with a last known or suspected CD4 count of <50/mm3
Subject has sustained extensive third-degree burns within the past 7 days
Subject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopenia
Subject is currently enrolled in an investigational drug or device trial
Subject has been previously enrolled in the current trial
Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment, such as end stage chronic illness with no reasonable expectation of survival to hospital discharge
Known hypersensitivity to hemofilter
Subject has received organ transplantation
Subject is expected to die within 24 hours

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Interventions

DEVICEblood purification(PS)

After the sepsis patients were enrolled, they were treated with blood purification in CVVH mode with PS membrane, 24 hours per day, for 3 consecutive days

DEVICEblood purification(AN69ST)

After the sepsis patients were enrolled, they were treated with blood purification in CVVH mode with AN69ST membrane, 24 hours per day, for 3 consecutive days