Comparing AN69ST and PS membranes for blood purification in children with sepsis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective cohort study comparing two blood purification membrane types (AN69ST versus PS) in children with sepsis who require continuous blood purification. Eligible patients are aged 29 days to 18 years with sepsis-induced multi-organ dysfunction or septic shock diagnosed within 48 hours. The study will follow clinical outcomes and inflammatory markers to compare efficacy and prognosis between the two membrane groups. Because randomized pediatric trials are scarce, this observational approach aims to generate evidence to guide membrane choice in pediatric critical care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

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

Study contacts

• Study coordinator: Jiayun Ying
• Email: jiayundoctor@163.com
• Phone: 18817583962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.