Burns
Conditions
Keywords
Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
Brief summary
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.
Detailed description
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
Interventions
DEVICEEfferon LPS NEO
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.
Sponsors
Efferon JSC
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Thermal burn of Ⅱ and Ⅲ severity with a lesion area of 40% or more (ICD-10: T20-T25, T29) * Frank index \>90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion) * Start of hemoadsorption no later than 5 days after admission to the ICU * The patient should receive adequate infusion therapy (at least 30 mL/kg) from the moment of inclusion in the study until the first sorption * The patient's condition allows Efferon LPS NEO therapy to be performed for at least 6 hours
Exclusion criteria
* Presence of end-stage renal disease * Acute pulmonary embolism, confirmed by CT scan * Uncontrolled bleeding (acute blood loss within the last 24 hours)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | 1-28 days | Time (days) from the start of hemoadsorption to transfer from the ICU |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support | 1-28 days | Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score) |
| Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function | 1-28 days | Value of oxygenation index (Pa02 / Fi02 (Pa)) |
| Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance | 1-28 days | Cummulative fluid balance in mL/kg |
| Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT) | 1-28 days | Duration of renal replacement therapy (RRT) in hours |
| Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions | 1-28 days | Frequency of surgical interventions (necrectomy) |
| Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality | 1-28 days | Mortality rate |
Countries
Russia
Contacts
Primary ContactAlexandr Shelehov-Kravchenko, PhD, MD
Outcome results
None listed