AN69ST Verse PS in CBP in Septic Children
- Conditions
- Sepsis
- Registration Number
- NCT05692011
- Lead Sponsor
- Children's Hospital of Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Meet the 2005 diagnostic criteria for sepsis<br><br> - Age 29 days - 18 years old<br><br> - Sepsis-induced dysfunction of more than one organ or abnormal tissue perfusion, or<br> septic shock<br><br> - Diagnosis < 48 hours<br><br>Exclusion Criteria:<br><br> - Inability to obtain an informed consent from the subject, family member or an<br> authorized surrogate<br><br> - Subject has end-stage renal disease and requires chronic dialysis<br><br> - There is clinical support for non-septic shock<br><br> - Subject has had chest compressions as part of cardiopulmonary resuscitation this<br> hospitalization without immediate return to communicative state<br><br> - Subject has uncontrolled hemorrhage<br><br> - Subject has immunodeficiency diseases<br><br> - Subject has received chemoradiotherapy or immunosuppressive therapy in the 14 days<br> before enrollment<br><br> - HIV infection in association with a last known or suspected CD4 count of <50/mm3<br><br> - Subject has sustained extensive third-degree burns within the past 7 days<br><br> - Subject has known sensitivity or allergy to heparin or has a history of heparin<br> associated thrombocytopenia<br><br> - Subject is currently enrolled in an investigational drug or device trial<br><br> - Subject has been previously enrolled in the current trial<br><br> - Any other condition, that in the opinion of the investigator, would preclude the<br> subject from being a suitable candidate for enrollment, such as end stage chronic<br> illness with no reasonable expectation of survival to hospital discharge<br><br> - Known hypersensitivity to hemofilter<br><br> - Subject has received organ transplantation<br><br> - Subject is expected to die within 24 hours
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cytokine change;organ injury changes
- Secondary Outcome Measures
Name Time Method survival rate