Early Haemadsorption in Major Burns

Study Overview
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Brief Summary
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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).

Official Title
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Early Haemadsorption Treatment of Major Burn Trauma Patients

Conditions
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Burns, Multiple Organ Failure, Shock, Organ Dysfunction Syndrome, Multiple, Renal Dysfunction, Cytokine Storm

Intervention / Treatment
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* Device: CytoSorb haemadsorption device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: informed consent of our patient or next of kin, TBSA >20% with 2/b depth of burn Exclusion Criteria: non-thermal burn injury, need for acute haemodialysis (intoxication), immunosuppressive treatment, chronic steroid use (> 3 months), known malignant disease, end-stage renal insufficiency or renal transplantation, Child C hepatic cirrhosis, gravidity, potentially lethal burn (Baux index >120) or comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients included in our study are randomised into treatment or control groups.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients are treated according to most recent guidelines in burn trauma and corresponding emergency and intensive therapy. All patients included are treated with early continous veno-venal renal replacement therapy. | |
| Active Comparator: Treatment group<br>Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion). | Device: CytoSorb haemadsorption device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 days mortality | The investigators assess the intensive care and post-intensive care mortality of our patients. | 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. | Survival rate is assessed in the 28th admission day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 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. | 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. | 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 | 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. | Assessed daily for each patient during the first week of our study. Worst results are registered. |