Early Haemadsorption in Major Burns

Not Applicable

• Conditions: Renal Dysfunction; Shock; Organ Dysfunction Syndrome, Multiple; Burns; Multiple Organ Failure; Cytokine Storm
• Interventions: Device: CytoSorb haemadsorption device

• Registration Number: NCT04195126
• Lead Sponsor: University of Pecs

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-05
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Study Start: 2020-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	CytoSorb haemadsorption device	Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion).

Primary Outcome Measures

Name	Time	Method
7 days mortality	Survival rate is assessed in the 7th admission day.	The investigators assess the intensive care and post-intensive care mortality of our patients.
28 days mortality	Survival rate is assessed in the 28th admission day.	The investigators assess the intensive care and post-intensive care mortality of our patients.

Secondary Outcome Measures

Name	Time	Method
Levels of inflammatory and anti-inflammatory cytokines during treatment	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.	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.
Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)	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.	The investigators follow the severity of oxidative stress in both groups.
Severity of organ failures according to SOFA point system	Assessed daily for each patient during the first week of our study. Worst results are registered.	The investigators assess the severity of multiple organ dysfunction/failure according to SOFA score.
Intensive Care Unit length of stay	Length of intensive care for each patient (days), data is registered through ICU discharge of the patient, an average of 1 month.	The investigators assessed the duration of ICU stay (in days)
Volume resuscitation fluid need of our patients.	Results are summarised daily for our patients during the first week following inclusion.	The investigators assess the primary volume resuscitation need of our patients.
Vasopressor need of our patients.	Results are summarised daily for our patients during the first week following inclusion.	The investigators assess the daily average vasopressor dose of our patients.
Length of mechanical ventilation (if needed).	Length of mechanical ventillation (days). Data is registered through patient discharge from ICU, an average of 1 month.	The investigators assess whether CytoSorb treatment reduce the length of mechanical ventilation

Trial Locations

Locations (1)

University of Pécs, Dept. of Anaesthesia and Intensive Care; 🇭🇺 Pécs, Baranya County, Hungary