Early Haemadsorption in Major Burns

Burns Clinical Trial

Official title:

Early Haemadsorption Treatment of Major Burn Trauma Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04195126
• Other study ID #: 7066 - PTE 2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2019
• Source: University of Pecs
• Contact: Gábor Woth, MD PhD
• Phone: +36703729231
• Email: glwoth[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Hungary	University of Pécs, Dept. of Anaesthesia and Intensive Care	Pécs	Baranya County

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.