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

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

This compares AN69ST and PS membranes during blood purification to see if one helps children with sepsis recover better.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 29 Days to 28 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05692011 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 29 days to 18 years with sepsis causing dysfunction of more than one organ or septic shock diagnosed within 48 hours and who are eligible for blood purification are ideal candidates.

Not a fit: Patients unlikely to benefit include those on chronic dialysis for end-stage renal disease, with non-septic shock, uncontrolled hemorrhage, severe immunodeficiency, recent chemoradiotherapy or immunosuppression, extensive recent burns, heparin allergy, or those unable to consent or present more than 48 hours after diagnosis.

Why it matters

Potential benefit: If successful, the results could identify which membrane better reduces inflammation and improves recovery and prognosis in children receiving blood purification for sepsis.

How similar studies have performed: Adult studies and some pediatric observational reports suggest blood purification can lower cytokines and improve hemodynamics, but randomized data in children comparing membrane types are very limited.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Jiayun Ying

Conditions Sepsis; sepsis; blood purification