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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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