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RecruitingNCT04794595Updated Mar 16, 2026

Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children

An observational study in Sepsis and Children, Only, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Children's Hospital of Fudan University · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
28 Days to 18 Years
Sex
All
01

Study summary

The effect of continuous blood purification (CBP) in children is unclear. Also, the timing of early application is still being explored. In this study, we need to explore the efficacy and the timing of application of CBP in children with sepsis or septic shock.

Read the detailed description

Early intervention of CBP can remove inflammatory factors in patients with sepsis and reduce the damage of inflammatory factors to organs; at the same time, it can also promote the body's immune response, significantly improve immune dysfunction, and restore the body's immune balance. However, the timing of early application of CBP in childhood sepsis is still unclear. Therefore, it is necessary to further explore the treatment and prognosis of this technology in the early treatment of sepsis.

02

Conditions studied

  • Sepsis
  • Children, Only

Browse trials for

Keywords

  • Continuous renal replacement therapy
  • sepsis
  • timing
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 90 is below the median of 160 across 931 observational 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
28 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children with sepsis requiring blood purification to prevent or treat fluid overload or to clear cytokines

Inclusion criteria

  • Age of 29d to 18 years old;
  • Children diagnosed with sepsis requiring blood purification.

Exclusion criteria

Exclusion Criteria:

  • with a history of a duration of PICU stay \<24 h
  • active bleeding, including cerebral hemorrhage
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • sepsis group with CBP

    The child with sepsis should be treated with CBP, but could not receive this treatment for various reasons

    Procedure: CBP

  • sepsis group without CBP

    The child with sepsis should be treated with CBP and received this treatment

Interventions

  • ProcedureCBP

    continuous blood purification can prevent or treat fluid overload in children with septic shock or other sepsis-associated organ dysfunction who are unresponsive to fluid restriction and diuretic therapy management of septic AKI patients, particularly those with hemodynamic instability or fluid overload. Also, it can remove cytokines

    Also known as: traditional therapy

06

What researchers measure

Primary outcomes

  1. survival rate

    The survival rate of children in 28 days after hospital discharge

    Time frame: 28 days after hospital discharge

Secondary outcomes

  1. The creatinine level of non-survival children with sepsis

    The creatinine level of non-survival children with sepsis in 28 days after hospital discharge

    Time frame: 28 days after hospital discharge

07

Study locations

1 of 1 sites recruiting
  • Children'S Hospital of Fudan University
    Shanghai, Shanghai Municipality 201102, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04794595
Lead sponsor
Children's Hospital of Fudan University
Collaborators
Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Mar 12, 2021
Start date
Dec 1, 2020
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Mar 16, 2026

Study contacts

YING JIAYUN
Contact
jiayundoctor@163.com
18817583962
Lu guoing
principal investigator · Children's Hospital of Fudan University

Oversight

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

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