NCT04195126

Early Haemadsorption in Major Burns

Early Haemadsorption Treatment of Major Burn Trauma Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Pecs · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	CytoSorb haemadsorption 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.

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-01-01
• Completion: 2023-07-01
• First posted: 2019-12-11
• Last updated: 2019-12-11

Locations

1 site across 1 country: Hungary