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This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.
Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain the leading causes of high mortality among severely burned patients. The Efferon® LPS NEO device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which is characterized by a complex inflammatory response. Burn trauma triggers the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may introduce pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore critical for effective burn injury management. The goal of the study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline therapy + Efferon LPS NEO | Patients will receive standart therapy for thermal burns treatments and Efferon LPS NEO hemoadsorption procedure. Prospective enrollement. |
| |
| Control group | The retrospective control group will include patients from the same medical institution's records from the previous 3 years, matched to the study cohort using propensity score matching. These patients received standard therapy for thermal burns, which could include hemofiltration or hemodiafiltration procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efferon LPS NEO | Device | Efferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | Time (days) from the start of hemoadsorption to transfer from the ICU | 1-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support | Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score) | 1-28 days |
| Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients with thermal burns undergoing treatment in Children's City Clinical Hospital No. 9 named after G.N. Speransky and Children's municipal multi-specialty clinical center of high medical technology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandr Shelehov-Kravchenko, PhD, MD | Contact | +79636564765 | alexandr.shelehov@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ivan Afukov, PhD, MD | Filatov Children's City Clinical Hospital of the Moscow Health Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department | Recruiting | Moscow | 123317 | Russia |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Value of oxygenation index (Pa02 / Fi02 (Pa)) |
| 1-28 days |
| Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance | Cummulative fluid balance in mL/kg | 1-28 days |
| Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT) | Duration of renal replacement therapy (RRT) in hours | 1-28 days |
| Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions | Frequency of surgical interventions (necrectomy) | 1-28 days |
| Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality | Mortality rate | 1-28 days |
| Children's municipal multi-specialty clinical center of high medical technology | Recruiting | Saint Petersburg | Russia |
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