Clinical trial NCT04195126: Early Haemadsorption in Major Burns
Official title: Early Haemadsorption Treatment of Major Burn Trauma Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Multiple Organ Failure
Shock
Organ Dysfunction Syndrome, Multiple
Renal Dysfunction
Cytokine Storm
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients included in our study are randomised into treatment or control groups.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: 7 days mortality
timeFrame: Survival rate is assessed in the 7th admission day.
measure: 28 days mortality
timeFrame: Survival rate is assessed in the 28th admission day.
Secondary outcomes:
measure: Levels of inflammatory and anti-inflammatory cytokines during treatment
timeFrame: 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.
measure: Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)
timeFrame: 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.
measure: Intensive Care Unit length of stay
timeFrame: Length of intensive care for each patient (days), data is registered through ICU discharge of the patient, an average of 1 month.
measure: Volume resuscitation fluid need of our patients.
timeFrame: Results are summarised daily for our patients during the first week following inclusion.
measure: Vasopressor need of our patients.
timeFrame: Results are summarised daily for our patients during the first week following inclusion.
measure: Length of mechanical ventilation (if needed).
timeFrame: Length of mechanical ventillation (days). Data is registered through patient discharge from ICU, an average of 1 month.
measure: Severity of organ failures according to SOFA point system
timeFrame: Assessed daily for each patient during the first week of our study. Worst results are registered.
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs, Dept. of Anaesthesia and Intensive Care
state: Baranya County
Study officials:
affiliation: University of Pécs, Dept. of Anaesthesia and Intensive Care
name: Gábor Woth, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: