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Not yet recruitingNCT05595239Updated Feb 17, 2026

Blood Purification in Septic Children

An interventional study of blood purification(CVVH) and blood purification(TPE+CVVH) in Sepsis and Blood Purification, sponsored by Children's Hospital of Fudan University. Not yet recruiting at 1 site in China. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
29 Days to 18 Years
Sex
All
01

Study summary

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 blood purifications on children with sepsis through randomized controlled studies, so as to provide a corresponding basis for the treatment of children with sepsis blood purification.

Read the 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. The main mechanisms are divided into dispersion, convection and adsorption. For sepsis, in addition to using the convection mechanism to remove the inflammatory mediators in the middle molecules, there are many adsorption membranes or adsorption columns used to adsorb the inflammatory factors in sepsis, so as to achieve the purpose of reducing the inflammatory mediators in the body. CVVH, HP and TPE can reduce the level of inflammation in the body in different ways, 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 in children with sepsis through a randomized controlled study. Provide the corresponding basis for blood purification treatment of the disease.

02

Conditions studied

  • Sepsis
  • Blood Purification

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03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's planned enrollment of 120 is above the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    standard treatment+CVVH

    Device: blood purification(CVVH)

  • Experimental
    standard treatment+TPE+CVVH

    Device: blood purification(TPE+CVVH)

  • Experimental
    standard treatment+HP+CVVH

    Device: blood purification(HP+CVVH)

Interventions

  • Deviceblood purification(CVVH)

    After the sepsis patients were enrolled, they were treated with blood purification in CVVH mode, 24 hours per day, for 3 consecutive days

  • Deviceblood purification(TPE+CVVH)

    After the sepsis patients were enrolled, they were treated with blood purification in TPE mode 2 hours at first and then in CVVH mode 22 hours in the first two days, and then in CVVH mode 24 hours

  • Deviceblood purification(HP+CVVH)

    After the sepsis patients were enrolled, they were treated with blood purification in HP mode 2 hours at first and then in CVVH mode 22 hours in the first two days, and then in CVVH mode 24 hours

06

What researchers measure

Primary outcomes

  1. cytokine change

    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

    Time frame: from enrollment to the 3th days

  2. organ injury changes

    the difference of the organ injury changes would be measured at the 3th day after enrollment

    Time frame: from enrollment to the 3th days

Secondary outcomes

  1. survival rate

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

    Time frame: from enrollment to the 28th days

07

Study locations

1 site
  • Lu Guoping
    Shanghai, Shanghai Municipality 201102, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05595239
Lead sponsor
Children's Hospital of Fudan University
Collaborators
First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Children's Hospital of Soochow University, Southern Medical University, China
Responsible party
Sponsor
First posted
Oct 26, 2022
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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