AN69ST Verse PS in CBP in Septic Children

February 12, 2026 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sepsis is a life-threatening organ dysfunction resulting from a dysregulated host response to infection. 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.

Blood purification therapy is gradually developed on the basis of renal replacement therapy, and now it is more and more widely used in the field of critical care in children. CVVH can reduce the level of inflammation in the body in different membranes, but the results of reducing inflammatory factors are different, and the outcomes of patients are also different.

Blood purification treatment can reduce inflammatory mediators in sepsis, but there are few prospective randomized controlled studies in children. Therefore, this study intends to compare the efficacy and prognosis of different blood purification membrane in children with sepsis through a perspective cohort study. Provide the corresponding basis for blood purification treatment of the disease.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201102
        • Recruiting
        • Children's Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 28 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

children with sepsis requiring blood purification

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
blood purification(AN69ST)
Device: blood 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
blood purification(PS)
Device: blood 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cytokine change
Time Frame: from enrollment to the 3th days
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
Time Frame: from enrollment to the 3th days
the difference of the organ injury changes would be measured at the 3th day after enrollment
from enrollment to the 3th days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival rate
Time Frame: from enrollment to the 28th days
the survival rate would be measured at the 28th day after enrollment
from enrollment to the 28th days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Collaborators

Shandong Provincial Hospital
First Affiliated Hospital of Xinjiang Medical University
Children's Hospital of Soochow University
Southern Medical University, China
West China Second University Hospital
Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fdpicu-28

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on blood purification(AN69ST)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe