Blood Purification in Septic Children

Sepsis Clinical Trial

Official title:

The Efficacy of Different Mode of Blood Purification in Septic Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05595239
• Other study ID #: fdpicu-26
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Subject is expected to die within 24 hours

Related Conditions & MeSH terms

• Blood Purification
• Sepsis

Intervention

Device:
• 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
• 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
• 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

Locations

Country	Name	City	State
China	Lu Guoping	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Children's Hospital of Soochow University, First Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	survival rate	the survival rate would be measured at the 28th day after enrollment	from enrollment to the 28th days