Blood Purification in Septic Children

NCT05595239 | Not Yet Recruiting

• 1 other identifier: fdpicu-26
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Blood Purification

Outcome Measures

Primary Outcomes (2)

• 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

  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

  from enrollment to the 3th days

Secondary Outcomes (1)

• survival rate

  from enrollment to the 28th days

Study Arms (3)

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)

Interventions

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

standard treatment+CVVH

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

standard treatment+TPE+CVVH

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

standard treatment+HP+CVVH

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Shandong Provincial Hospital: collaborator
• Children's Hospital of Soochow University: collaborator
• Southern Medical University, China: collaborator

Study Sites (1)

Lu Guoping

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 26, 2022
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)