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Trial record 25 of 36 for:    Cytosorb

Early Haemadsorption in Major Burns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04195126
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
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).

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195126


Contacts
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Contact: Gábor Woth, MD PhD +36703729231 glwoth@gmail.com
Contact: Tamás Kiss, MD PhD kisstamasmd@gmail.com

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

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Responsible Party: University of Pecs
ClinicalTrials.gov Identifier: NCT04195126    
Other Study ID Numbers: 7066 - PTE 2018
First Posted: December 11, 2019    Key Record Dates
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Multiple Organ Failure
Burns
Wounds and Injuries
Kidney Diseases
Urologic Diseases
Shock
Pathologic Processes