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Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

ConditionBurns
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorEfferon JSC

About this trial

This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into 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 a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.

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)

Burn disease in the stage of acute toxemia or septicemia

Frank Index ≥ 90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)

The patient's condition allows for Efferon LPS therapy for at least 6 hours

Disqualifiers

Isolated thermal inhalation injury

Charlson Comorbidity Index > 8

Dementia

End-stage renal failure

Trial population

Adult patients with thermal burns undergoing treatment in State Novosibirsk Regional Clinical Hospital

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Efferon LPS

    Device

    Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Control group0 interventions
Group B: Baseline therapy + Efferon LPS1 intervention

Trial outcomes

Primary outcomes

1

Effect of the Efferon LPS hemoadsorption on 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 hemoadsorption on need for vasopressor support

Need for vasopressors according to the VIS 2020 scale (Vasoactive-Inotropic Score), a weighted sum of vasoactive and inotropic medication doses; higher scores indicate greater hemodynamic support requirement (worse outcome).

Time frame
1-28 days
2

Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function

Value of oxygenation index (PaO₂/FiO₂ (Pa)) Oxygenation index (PaO₂/FiO₂) = arterial oxygen partial pressure (Pa02, mmHg) / the fraction of inspired oxygen (FiO2).

Time frame
1-28 days
3

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

Duration of renal replacement therapy (RRT) in hours

Time frame
1-28 days
4

Effect of the Efferon LPS hemoadsorption on incidence of septic complications

Frequency of septic complications

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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