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NCT Number: NCT05692011

AN69ST Verse PS in CBP in Septic Children

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.

Recruiting

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Key information

Age range

29 day–28 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

Jiayun Ying

CONTACT

[email protected]

+86 18817583962

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood purification(PS)

Device

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

blood purification(AN69ST)

Device

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. survival rate

    Time frame: from enrollment to the 28th days

    the survival rate would be measured at the 28th day after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Guoping Lu

CONTACT

[email protected]

13788904150

Jiayun Ying

CONTACT

[email protected]

18817583962

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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