Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis

Launched by EFFERON JSC · Jan 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called Efferon LPS NEO, which uses a special device to help remove harmful substances from the blood of children suffering from sepsis. Sepsis is a serious condition that can happen when the body has a severe response to an infection, and it can lead to multiple organ failure. The goal of the study is to find out if this treatment is both safe and effective for children aged 1 month to 14 years who have been diagnosed with sepsis within the last 12 hours.

To be eligible to participate in this trial, children must weigh between 5 kg and 40 kg and have a specific level of illness based on a scale used by doctors. They should also be able to tolerate the treatment for at least 4 hours. Participants will receive the new treatment, and researchers will monitor their progress to see how well it works. It’s important to note that some children may not qualify for the study if they have certain medical conditions or if consent cannot be obtained from their parents or guardians.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Weight from 5 kg. up to 40 kg (main criterion),
• • Age from 1 month to 14 years,
• • No more than 12 hours from the moment of establishment of DZ - Sepsis in accordance with the criteria of SEPSIS-3 (2016, modified for childhood), most likely, Gr-etiology, at the time of inclusion.
• • The immediate postoperative period in case of abdominal nature of sepsis (no more than 12 hours after surgery),
• • If the patient has a focus of surgical infection, then it should be sanitized,
• • pSOFA scale ≥ 6 points, or an increase in negative dynamics on the pSOFA scale by 2 or more points over 12 hours of observation,
• • The patient's condition allows for therapy with the Efferon LPS NEO column for at least 4 hours.
• Exclusion Criteria:
• • Weight below 5 kg and over 40 kg,
• • Age less than 1 month and over 14 years old,
• • Failure to obtain informed consent from the patient's parents, family member or legal representative,
• • The presence of a focus of non-sanitized surgical infection,
• • Use in the treatment of other methods of extracorporeal removal of LPS and inflammatory mediators (hemofilters with highly permeable and surface-modified membranes),
• • Acute pulmonary embolism,
• • Intracranial hemorrhage or bleeding tendency in general,
• • Induced aplasia of hematopoiesis,
• • If it is impossible to provide vascular access necessary for the method,
• • Any other condition that, in the opinion of the Investigator, would prevent the patient from being a suitable candidate for inclusion in the trial (for example, a chronic disease in the terminal stage or a mental disorder that affects the methodology for conducting a hemoperfusion procedure, as well as for patients who have a "palliative status ").