Blood Purification in Septic Children

Fudan University

Status

Not yet enrolling

Conditions

Blood Purification

Sepsis

Treatments

Device: blood purification(TPE+CVVH)

Device: blood purification(CVVH)

Device: blood purification(HP+CVVH)

Study type

Interventional

Funder types

Other

Identifiers

NCT05595239

fdpicu-26

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

29 days to 18 years old

Volunteers

No Healthy Volunteers

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