Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Extracorporeal Blood Purification Using Efferon LPS Hemoadsorption in Patients With Thermal Burns: Pilot Study
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Burn injury is not only a local tissue injury at the site of the damaging agent, but also triggers a complex systemic response to trauma. Severe burn injury induces a systemic inflammatory response associated with generalized microcirculatory disturbances in organs and tissues, cellular dystrophy and destruction, and the development of multiple organ dysfunction and failure. Burn trauma causes massive release of damage-associated molecular patterns (DAMPs) and pro-inflammatory cytokines, leading to systemic inflammatory response syndrome (SIRS), which may result in multiple organ failure and death. Mortality associated with multiple organ failure in burn patients reaches 81-87% among patients who develop this condition, and multiple organ failure remains the leading cause of death in burn patients. Among patients with a Sequential Organ Failure Assessment (SOFA) score ≥4 within the first 24 hours after injury, mortality reaches 81%.
The Efferon LPS hemoadsorption device was developed for use in sepsis, leveraging its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential in the treatment of burn injury, a condition characterized by a complex inflammatory response.
The goal of this 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 manifestations and to prevent progression of multiple organ dysfunction, or mitigate it if already developed, in patients with burn disease and an RFI score ≥71 and ≤181.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Alexandr Shelehov-Kravchenko, PhD, MD
- Puhelinnumero: +79636564765
- Sähköposti: ais@efferon.ru
Opiskelupaikat
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Moscow, Venäjä, 129090
- N.V. Sklifosovsky Research Institute for Emergency Medicine
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Ottaa yhteyttä:
- Vladimir Kulabukhov, PhD, MD
- Puhelinnumero: +79255068081
- Sähköposti: v.kulabukhov@gmail.com
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Cardiopulmonary resuscitation at the pre-hospital stage
- End-stage renal disease
- Acute pulmonary embolism confirmed by imaging
- Emergency surgical treatment
- Any other condition which, in the investigator's opinion, precludes inclusion of the patient in the study
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Ei väliintuloa: Baseline therapy
Patients receiving standard treatment for the treatment of thermal burns without the use of hemoadsorption methods, but who are prescribed continuous renal replacement therapy (CRRT) for renal and non-renal indications.
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Kokeellinen: Baseline therapy + Efferon LPS
Patients receiving standard therapy for the treatment of thermal burns, along with Efferon LPS hemoadsorption procedures in combination with continuous renal replacement therapy (CRRT).
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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).
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Need for vasopressor support
Aikaikkuna: 1-28 days
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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.
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1-28 days
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Horowitz oxygenation index
Aikaikkuna: 1-28 days
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Value of oxygenation index (Pa02 / Fi02 (Pa).
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1-28 days
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Renal replacement therapy (RRT) free days
Aikaikkuna: 1-28 days
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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. |
1-28 days
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28 and 60 days mortality
Aikaikkuna: 1-60 days
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Mortality rate
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1-60 days
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Length of stay in the intensive care unit
Aikaikkuna: 1-60 days
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Time (number of days) from study enrollment to transfer from the intensive care unit within 60 days
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1-60 days
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Duration of hospitalization
Aikaikkuna: 1-60 days
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Time (number of days) from study enrollment to discharge from the hospital
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1-60 days
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Frequency of septic complications
Aikaikkuna: 1-28 days
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Percentage of patients with septic complications
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1-28 days
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Frequency of surgical interventions
Aikaikkuna: 1-28 days
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Percentage of patients requiring surgery
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1-28 days
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Vladimir Kulabukhov, PhD, MD, N.V. Sklifosovsky Research Institute for Emergency Medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
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Muita asiaankuuluvia MeSH-ehtoja
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