Early Haemadsorption in Major Burns

University of Pecs

Status: Unknown

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

Treatments: Device: CytoSorb haemadsorption device

Study type: Interventional

Funder types: Other

Identifiers

NCT04195126

7066 - PTE 2018

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion).

Treatment:

Device: CytoSorb haemadsorption device