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Efferon LPS Hemoadsorption in in Patients With Thermal Burns

ConditionBurns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEfferon JSC

About this trial

The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression of multiple organ dysfunction or to arrest its development in patients with burn disease with an RFI score ≥71 and ≤181.

Patients will be randomized in two groups: control group receiving baseline therapy (including CRRT) and treatment group receiving baseline therapy and Efferon® LPS hemoadsorption in combination with CRRT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Thermal burns (flame, scald, or contact burns), including cases combined with inhalation injury

Revised Frank Index (RFI) score ≥71 and ≤181

Indication for extracorporeal therapy within the first 10 days after injury

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

Disqualifiers

Isolated thermal-inhalation injury

Chemical, electrical, or solar burns of the skin

Combined skin burns with frostbite and/or general hypothermia

Combined trauma (electrical injury; traumatic brain injury other than concussion or mild cerebral contusion; skull, spinal, thoracic, pelvic, or femoral fractures) or acute pre-existing pathology prior to hospital admission (acute myocardial infarction, stroke, community-acquired pneumonia, or acute surgical conditions) that may influence the course and outcome of burn disease

Trial design

Design model

Parallel

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.hemoadsorption procedures, each lasting 6-12 hours, with an interval of at least 24 hours between hemoadsorption sessions (from the start of the first procedure). The procedures are performed in combination with continuous renal replacement therapy (CRRT).

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Baseline therapyNo intervention 0 interventions
Group B: Baseline therapy + Efferon LPSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Need for vasopressor support

Need for vasopressors according to the Vasoactive inotropic score (VIS 2020) heart rate scale. VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.

Time frame
1-28 days

Secondary outcomes

1

Horowitz oxygenation index

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

Time frame
1-28 days
2

Renal replacement therapy (RRT) free days

RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. RRT-free days = 0 if the subject requires RRT for more than 28 days.

Time frame
1-28 days
3

28 and 60 days mortality

Mortality rate

Time frame
1-60 days
4

Length of stay in the intensive care unit

Time (number of days) from study enrollment to transfer from the intensive care unit within 60 days

Time frame
1-60 days

Other outcomes

Sponsors and contacts

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

Efferon JSC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: