AN69ST Verse PS in CBP in Septic Children
The Effects of a AN69ST Membrane and Polysulphone Membrane on Septic Children With Continuous Blood Purification
1 other identifier
observational
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2025
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 17, 2026
February 1, 2026
1.2 years
January 11, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
cytokine change
This is a binary variable. It is also a compositional variable including IL-6, IL-10, TNF-a, IL-4, IL-2 and etc. If one of the factors changes, it is considered that the variable changes. If the cytokine drops below half of the original value, it is considered to be changed. The cytokine would be measured measured at the 7th day after enrollment
from enrollment to the 3th days
organ injury changes
the difference of the organ injury changes would be measured at the 3th day after enrollment
from enrollment to the 3th days
Secondary Outcomes (1)
survival rate
from enrollment to the 28th days
Study Arms (2)
blood purification(AN69ST)
blood purification(PS)
Interventions
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
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
Eligibility Criteria
children with sepsis requiring blood purification
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- First Affiliated Hospital of Xinjiang Medical Universitycollaborator
- Southern Medical University, Chinacollaborator
- Children's Hospital of Chongqing Medical Universitycollaborator
- Shandong Provincial Hospitalcollaborator
- Children's Hospital of Soochow Universitycollaborator
- Children's Hospital of Fudan Universitylead
- West China Second University Hospitalcollaborator
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Biospecimen
the volume of 2ml whole blood was stored in EDTA tube
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 20, 2023
Study Start
October 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02