- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04794595
Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children
March 13, 2026 updated by: Children's Hospital of Fudan University
Clinical Features and Outcomes of Continuous Blood Purification Versus Non-continuous Blood Purification in Pediatric Patients With Sepsis or Septic Shock
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.
Study Overview
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.
Study Type
Observational
Enrollment (Estimated)
90
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
- Name: YING JIAYUN
- Phone Number: 18817583962
- Email: jiayundoctor@163.com
Study Locations
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 201102
- Recruiting
- Children's Hospital of Fudan University
-
Contact:
- YING JIAYUN
- Phone Number: 18817583962
- Email: jiayundoctor@163.com
-
-
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 18 years (Child, Adult)
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
Description
Inclusion Criteria:
- Age of 29d to 18 years old;
- Children diagnosed with sepsis requiring blood purification.
Exclusion Criteria:
- with a history of a duration of PICU stay <24 h
- active bleeding, including cerebral hemorrhage
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 |
|---|---|
|
sepsis group with CBP
The child with sepsis should be treated with CBP, but could not receive this treatment for various reasons
|
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
Other Names:
|
|
sepsis group without CBP
The child with sepsis should be treated with CBP and received this treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
survival rate
Time Frame: 28 days after hospital discharge
|
The survival rate of children in 28 days after hospital discharge
|
28 days after hospital discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The creatinine level of non-survival children with sepsis
Time Frame: 28 days after hospital discharge
|
The creatinine level of non-survival children with sepsis in 28 days after hospital discharge
|
28 days after hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lu guoing, Children's Hospital of Fudan 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)
December 1, 2020
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 12, 2021
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- fdpicu-08
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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-
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