Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Sepsis (LASSONEO)
Sepsis, Septic Shock
About this trial
This is an interventional treatment trial for Sepsis focused on measuring septic shock, sepsis, extracorporeal therapy, LPS adsorption
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 ").
Sites / Locations
- Filatov Children's City Clinical Hospital of the Moscow Health DepartmentRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Basic therapy + Efferon LPS NEO
Baseline therapy
Study group: Basic therapy + Efferon LPS NEO - 80 patients, prospective enrollment.
Control group: Basic therapy - 160 patients, retrospective enrollment. Basic therapy is the routine practice of the institution for the treatment of patients with sepsis (conservative anti-infective therapy). Antibacterial therapy regimens, antibiotic dosage adjustment regimens for AKI and prolonged RRT procedures are not specifically prescribed in the CT Plan.