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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | 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. | |
| Treatment group | Active Comparator | Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb haemadsorption device | Device | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gábor Woth, MD PhD | Contact | +36703729231 | glwoth@gmail.com | |
| Tamás Kiss, MD PhD | Contact | kisstamasmd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gábor Woth, MD PhD | University of Pécs, Dept. of Anaesthesia and Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pécs, Dept. of Anaesthesia and Intensive Care | Pécs | Baranya | 7622 | Hungary |
The investigators plan to share patient clinical data and laboratory measurement results following study result publication.
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| ID | Term |
|---|---|
| D002056 | Burns |
| D009102 | Multiple Organ Failure |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
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Patients included in our study are randomised into treatment or control groups.
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Outcome assessors are unaware of the patient groups. Treated patients are not informed regarding randomisation results.
| 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. |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |