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NCT05692011
AN69ST Verse PS in CBP in Septic Children
Conditions: Sepsis
Sex: All
Ages: 29 Days – 28 Years
Enrollment: 80
Sponsor: Children's Hospital of Fudan University
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 membrane on children with sepsis through a perspective cohort study, so as to provide a corresponding basis for the treatment of children with sepsis blood purification.
Eligibility Criteria
Inclusion Criteria:Meet the 2005 diagnostic criteria for sepsisAge 29 days - 18 years oldSepsis-induced dysfunction of more than one organ or abnormal tissue perfusion, or septic shockDiagnosis < 48 hoursExclusion Criteria:Inability to obtain an informed consent from the subject, family member or an authorized surrogateSubject has end-stage renal disease and requires chronic dialysisThere is clinical support for non-septic shockSubject has had chest compressions as part of cardiopulmonary resuscitation this hospitalization without immediate return to communicative stateSubject has uncontrolled hemorrhageSubject has immunodeficiency diseasesSubject has received chemoradiotherapy or immunosuppressive therapy in the 14 days before enrollmentHIV infection in association with a last known or suspected CD4 count of <50/mm3Subject has sustained extensive third-degree burns within the past 7 daysSubject has known sensitivity or allergy to heparin or has a history of heparin associated thrombocytopeniaSubject is currently enrolled in an investigational drug or device trialSubject has been previously enrolled in the current trialAny 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 dischargeKnown hypersensitivity to hemofilterSubject has received organ transplantationSubject is expected to die within 24 hours
Source: ClinicalTrials.gov (NCT05692011). StuddyBuddy aggregates publicly available trial information.