Early Haemadsorption in Major Burns

Early Haemadsorption Treatment of Major Burn Trauma Patients

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Shock; Multiple Organ Failure; Cytokine Storm; Renal Dysfunction; Organ Dysfunction Syndrome, Multiple
• Intervention / Treatment: Device: CytoSorb haemadsorption device

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gábor Woth, MD PhD; Phone Number: +36703729231; Email: glwoth@gmail.com
• Study Contact Backup: Name: Tamás Kiss, MD PhD; Email: kisstamasmd@gmail.com

Study Locations

• Hungary
  • Baranya County
    • Pécs, Baranya County, Hungary, 7622
      • University of Pécs, Dept. of Anaesthesia and Intensive Care
      • Principal Investigator: Gábor Woth, MD PhD
      • Sub-Investigator: Bálint Nagy, MD PhD
      • Contact: Gábor Woth, MD PhD; Phone Number: +36703729231; Email: woth.gabor@pte.hu
      • Contact: Tamás Kiss, MD PHD; Email: kiss.tamas@pte.hu
      • Sub-Investigator: Tamás Kiss, MD PhD
      • Sub-Investigator: Zsófia Kriszta, MD
      • Sub-Investigator: Krisztina Kovács, MD PHD
      • Sub-Investigator: Lajos Bogár, MD PhD Prof
      • Sub-Investigator: Diana Mühl, MD PHD Prof
      • Sub-Investigator: Csaba Csontos, MD PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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.
Active Comparator: Treatment group; Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Principal Investigator: Gábor Woth, MD PhD, University of Pécs, Dept. of Anaesthesia and Intensive Care

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: May 5, 2018
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Wounds and Injuries; Shock; Burns; Renal Insufficiency; Cytokine Release Syndrome; Multiple Organ Failure
• Other Study ID Numbers: 7066 - PTE 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The investigators plan to share patient clinical data and laboratory measurement results following study result publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No