Blood Purification in Septic Children

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Oct 23, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how different blood purification methods can help children with sepsis. Sepsis is a serious condition where the body has a strong reaction to an infection, which can lead to organ damage and make it harder for the body to recover. The study aims to compare the effectiveness of these blood purification techniques in reducing harmful substances in the blood and improving health outcomes for children suffering from sepsis.

To participate in this trial, children aged between 29 days and 18 years who meet specific criteria may be eligible. This includes those diagnosed with sepsis within the last 48 hours and experiencing problems with more than one organ or having septic shock. Families should know that participants might undergo a new type of blood treatment and will be closely monitored by medical professionals throughout the trial. Importantly, the study is not yet recruiting participants, so it will be some time before it starts.

Gender

ALL

Eligibility criteria

• 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