Major deep burns (\>20% body surface, involving deep skin layers) and associated severe inflammatory reaction and their complication are one of the biggest challenge of intensive care. Haemoadsorption therapy, including the CytoSorb treatment is a promising novel therapeutic approach, but only case-studies are available in the literature yet. Based on data from septic shock patient treatment the investigators hypothesize that CytoSorb is beneficial in early treatment of burns. The investigators aim to conduct a randomised-controlled study to assess the clinical effectiveness (based on score systems including MODS, SOFA, APACHE II, KDIGO, ABSI), 7 and 28 days survival, intensive care length of stay, length of mechanical ventilation, resuscitation fluid need and ino/vasopressor drug doses and the presence and severity of organ dysfunctions, particularly renal dysfunction. The investigatora plan to conduct basic research to elucidate the pathophysiological background of clinical effect, including the measurement of inflammatory and anti-inflammatory cytokines, presence and severity of oxidative stress (lipid peroxidation, protein oxidation, reduced/oxidised glutathion levels) and organ dysfunction markers (kidney injury molecule -1, neutrophil gelatinase-associated lipocalin, cystatin-C, uromodulin).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
CytoSorb (Cytosorbents Inc.) aspecific blood purification device used in an extracorporeal circulation system without dialysis column. Anticoagulation is managed by siodium citrate-Calcium system, using the Gambro CVVHDF capable device.
University of Pécs, Dept. of Anaesthesia and Intensive Care
Pécs, Baranya, Hungary
7 days mortality
The investigators assess the intensive care and post-intensive care mortality of our patients.
Time frame: Survival rate is assessed in the 7th admission day.
28 days mortality
The investigators assess the intensive care and post-intensive care mortality of our patients.
Time frame: Survival rate is assessed in the 28th admission day.
Levels of inflammatory and anti-inflammatory cytokines during treatment
The investigators assess the course of pro- and anti-inflammatory cytokines during ICU stay for both patient groups. Cytokines are screened by the Human Cytokine Array. Selected markers are measured individually.
Time frame: Samples are gathered on inclusion and 8, 16, 24, 48, 72, 96, 120, 148, 168 hours following. Measured data points are selected by screening. All measurements are carried out in one lot. Data will be presented in arbitrary units.
Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)
The investigators follow the severity of oxidative stress in both groups.
Time frame: Samples are gathered on inclusion and 8, 16, 24, 48, 72, 96, 120, 148, 168 hours following. Measured data points are selected by screening. All measurements are carried out in one lot.
Intensive Care Unit length of stay
The investigators assessed the duration of ICU stay (in days)
Time frame: Length of intensive care for each patient (days), data is registered through ICU discharge of the patient, an average of 1 month.
Volume resuscitation fluid need of our patients.
The investigators assess the primary volume resuscitation need of our patients.
Time frame: Results are summarised daily for our patients during the first week following inclusion.
Vasopressor need of our patients.
The investigators assess the daily average vasopressor dose of our patients.
Time frame: Results are summarised daily for our patients during the first week following inclusion.
Length of mechanical ventilation (if needed).
The investigators assess whether CytoSorb treatment reduce the length of mechanical ventilation
Time frame: Length of mechanical ventillation (days). Data is registered through patient discharge from ICU, an average of 1 month.
Severity of organ failures according to SOFA point system
The investigators assess the severity of multiple organ dysfunction/failure according to SOFA score.
Time frame: Assessed daily for each patient during the first week of our study. Worst results are registered.
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