Early Haemadsorption in Major Burns

• ClinicalTrials.gov Identifier: NCT04195126
• Recruitment Status: Not yet recruiting
• First Posted: December 11, 2019
• Last Update Posted: December 11, 2019
• Sponsor: University of Pecs
• Information provided by (Responsible Party): University of Pecs

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Burns; Multiple Organ Failure; Shock; Organ Dysfunction Syndrome, Multiple; Renal Dysfunction; Cytokine Storm	Device: CytoSorb haemadsorption device	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients included in our study are randomised into treatment or control groups.
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Outcome assessors are unaware of the patient groups. Treated patients are not informed regarding randomisation results.
• Primary Purpose: Treatment
• Official Title: Early Haemadsorption Treatment of Major Burn Trauma Patients
• Estimated Study Start Date: January 1, 2020
• Estimated Primary Completion Date: January 1, 2023
• Estimated Study Completion Date: July 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 7 days mortality [ Time Frame: Survival rate is assessed in the 7th admission day. ]
   The investigators assess the intensive care and post-intensive care mortality of our patients.
2. 28 days mortality [ Time Frame: 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 :

1. Levels of inflammatory and anti-inflammatory cytokines during treatment [ Time Frame: 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.
2. Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers) [ Time Frame: 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.
3. Intensive Care Unit length of stay [ Time Frame: 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)
4. Volume resuscitation fluid need of our patients. [ Time Frame: Results are summarised daily for our patients during the first week following inclusion. ]
   The investigators assess the primary volume resuscitation need of our patients.
5. Vasopressor need of our patients. [ Time Frame: Results are summarised daily for our patients during the first week following inclusion. ]
   The investigators assess the daily average vasopressor dose of our patients.
6. Length of mechanical ventilation (if needed). [ Time Frame: 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
7. Severity of organ failures according to SOFA point system [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Gábor Woth, MD PhD; +36703729231; glwoth@gmail.com

Contact: Tamás Kiss, MD PhD; kisstamasmd@gmail.com

Locations

Hungary

University of Pécs, Dept. of Anaesthesia and Intensive Care

Pécs, Baranya County, Hungary, 7622

Contact: Gábor Woth, MD PhD +36703729231 woth.gabor@pte.hu

Contact: Tamás Kiss, MD PHD kiss.tamas@pte.hu

Principal Investigator: Gábor Woth, MD PhD

Sub-Investigator: Bálint Nagy, MD PhD

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

Sponsors and Collaborators

University of Pecs

Investigators

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

More Information

• Responsible Party: University of Pecs
• ClinicalTrials.gov Identifier: NCT04195126
• Other Study ID Numbers: 7066 - PTE 2018
• First Posted: December 11, 2019
• Last Update Posted: December 11, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Renal Insufficiency; Multiple Organ Failure; Burns; Wounds and Injuries; Kidney Diseases; Urologic Diseases; Shock; Pathologic Processes