SepsisNCT05595239
Blood Purification in Septic Children
A study testing blood purification(CVVH), blood purification(TPE+CVVH) and blood purification(HP+CVVH) in people with Sepsis and Blood Purification, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Sepsis, Blood Purification
- What is being tested?
- blood purification(CVVH), blood purification(TPE+CVVH) and blood purification(HP+CVVH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- 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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
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
Lu Guoping
Shanghai, Shanghai Municipality, 201102
YING JIAYUN, 18817583962, jiayundoctor@163.com
About this study
Official title: The Efficacy of Different Mode of Blood Purification 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 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.
- Conditions
- Sepsis, Blood Purification
- Being tested
- blood purification(CVVH), blood purification(TPE+CVVH), blood purification(HP+CVVH)
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood purification(CVVH)Device
After the sepsis patients were enrolled, they were treated with blood purification in CVVH mode, 24 hours per day, for 3 consecutive days
blood purification(TPE+CVVH)Device
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
blood purification(HP+CVVH)Device
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
| Study group | Role | What they receive |
|---|---|---|
| standard treatment+CVVH | Experimental | Not described Receives: Device: blood purification(CVVH) |
| standard treatment+TPE+CVVH | Experimental | Not described Receives: Device: blood purification(TPE+CVVH) |
| standard treatment+HP+CVVH | Experimental | Not described Receives: Device: blood purification(HP+CVVH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to the 3th days
organ injury changes
the difference of the organ injury changes would be measured at the 3th day after enrollment
Measured: from enrollment to the 3th days
Secondary outcomes (1)
survival rate
the survival rate would be measured at the 28th day after enrollment
Measured: from enrollment to the 28th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Children's Hospital of Soochow University, Southern Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595239
- Sponsor's protocol ID
- fdpicu-26
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2022
- Last updated
- 27 Oct 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Different Mode of Blood Purification in Septic Children
- ClinicalTrials.gov ID
- NCT05595239
- Acronym / sponsor ID
- fdpicu-26
- Conditions
- Sepsis, Blood Purification
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Children's Hospital of Soochow University, Southern Medical University, China
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2022 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard treatment+CVVH | Experimental | Device: blood purification(CVVH) |
| standard treatment+TPE+CVVH | Experimental | Device: blood purification(TPE+CVVH) |
| standard treatment+HP+CVVH | Experimental | Device: blood purification(HP+CVVH) |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| blood 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 | Device | standard treatment+CVVH |
| blood 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 | Device | standard treatment+TPE+CVVH |
| blood 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 | Device | standard treatment+HP+CVVH |
Primary outcome
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
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
1 secondary outcome
survival rate
Time frame: from enrollment to the 28th days
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 27 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood purification(CVVH), blood purification(TPE+CVVH) and blood purification(HP+CVVH) in people with Sepsis and Blood Purification, 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 4 inclusion and 16 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: opening soon, as of the sponsor's last update on 27 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine change (time frame: from enrollment to the 3th days). The study lists 2 primary outcomes in all. 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 27 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.