Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns
ConditionBurns
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-14
SponsorEfferon JSC
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Presence of end-stage renal disease
Acute pulmonary embolism, confirmed by CT scan
Uncontrolled bleeding (acute blood loss within the last 24 hours)
Trial design
Treatments tested in this trial
- Efferon LPS NEO
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov