SepsisNCT04794595
Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children
An observational study of Sepsis and Children, Only, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Sepsis, Children, Only
- What is being tested?
- CBP
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with sepsis requiring blood purification to prevent or treat fluid overload or to clear cytokines
Who may be able to join
- Age of 29d to 18 years old;
- Children diagnosed with sepsis requiring blood purification.
Who cannot join
- with a history of a duration of PICU stay <24 h
- active bleeding, including cerebral hemorrhage
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children'S Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
YING JIAYUN, 18817583962, jiayundoctor@163.com
About this study
Official title: 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.
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.
- Conditions
- Sepsis, Children, Only
- Being tested
- CBP
- Keywords
- Continuous renal replacement therapy, sepsis, timing
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBPProcedure or surgery
Also called traditional therapy
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
| Study group | Role | What they receive |
|---|---|---|
| sepsis group with CBP | The child with sepsis should be treated with CBP， but could not receive this treatment for various reasons Receives: Procedure: CBP | |
| sepsis group without CBP | The child with sepsis should be treated with CBP and received this treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
The survival rate of children in 28 days after hospital discharge
Measured: 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
Measured: 28 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Dec 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Lu guoing, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794595
- Sponsor's protocol ID
- fdpicu-08
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Outcomes of Continuous Blood Purification Versus Non-continuous Blood Purification in Pediatric Patients With Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT04794595
- Acronym / sponsor ID
- fdpicu-08
- Conditions
- Sepsis, Children, Only
- Keywords
- Continuous renal replacement therapy, sepsis, timing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Hospital, Shanghai Children's Medical Center, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis group with CBP | – | Procedure: CBPThe child with sepsis should be treated with CBP， but could not receive this treatment for various reasons |
| sepsis group without CBP | – | –The child with sepsis should be treated with CBP and received this treatment |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with sepsis requiring blood purification to prevent or treat fluid overload or to clear cytokines
Key inclusion criteria (2 listed)
- Age of 29d to 18 years old;
- Children diagnosed with sepsis requiring blood purification.
Key exclusion criteria (2 listed)
- with a history of a duration of PICU stay <24 h
- active bleeding, including cerebral hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBPAlso: traditional therapycontinuous 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 | Procedure or surgery | sepsis group with CBP |
Primary outcome
survival rate
Time frame: 28 days after hospital discharge
The survival rate of children in 28 days after hospital discharge
1 secondary outcome
The creatinine level of non-survival children with sepsis
Time frame: 28 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lu guoing principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Children, Only, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YING JIAYUN (18817583962, jiayundoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 28 days after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.