Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Baseline therapy + Efferon LPS NEO1 intervention
Group B: Control group0 interventions

Trial outcomes

Primary outcomes

1

ICU length of stay

Time (days) from the start of hemoadsorption to transfer from the ICU

Time frame
1-28 days

Secondary outcomes

1

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)

Time frame
1-28 days
2

Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function

Value of oxygenation index (Pa02 / Fi02 (Pa))

Time frame
1-28 days
3

Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance

Cummulative fluid balance in mL/kg

Time frame
1-28 days
4

Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)

Duration of renal replacement therapy (RRT) in hours

Time frame
1-28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Efferon JSC

Lead sponsor

Source ClinicalTrials.gov
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