Blood Purification in Septic Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-18
SponsorChildren's Hospital of Fudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
blood purification(CVVH)
DeviceAfter 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)
DeviceAfter 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)
DeviceAfter 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
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: standard treatment+CVVHExperimental treatment 1 intervention
Group B: standard treatment+TPE+CVVHExperimental treatment 1 intervention
Group C: standard treatment+HP+CVVHExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
from enrollment to the 3th days2
organ injury changes
the difference of the organ injury changes would be measured at the 3th day after enrollment
Time frame
from enrollment to the 3th daysSecondary outcomes
1
survival rate
the survival rate would be measured at the 28th day after enrollment
Time frame
from enrollment to the 28th daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Shandong Provincial Hospital
Collaborator
Children's Hospital of Soochow University
Collaborator
Southern Medical University, China
Collaborator
Source ClinicalTrials.gov
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