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Early Haemadsorption in Major Burns

Primary Purpose

Burns, Multiple Organ Failure, Shock

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
CytoSorb haemadsorption device
Sponsored by
University of Pecs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pécs, Dept. of Anaesthesia and Intensive Care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Treatment group

Arm Description

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.

Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion).

Outcomes

Primary Outcome Measures

7 days mortality
The investigators assess the intensive care and post-intensive care mortality of our patients.
28 days mortality
The investigators assess the intensive care and post-intensive care mortality of our patients.

Secondary Outcome Measures

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.
Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)
The investigators follow the severity of oxidative stress in both groups.
Intensive Care Unit length of stay
The investigators assessed the duration of ICU stay (in days)
Volume resuscitation fluid need of our patients.
The investigators assess the primary volume resuscitation need of our patients.
Vasopressor need of our patients.
The investigators assess the daily average vasopressor dose of our patients.
Length of mechanical ventilation (if needed).
The investigators assess whether CytoSorb treatment reduce the length of mechanical ventilation
Severity of organ failures according to SOFA point system
The investigators assess the severity of multiple organ dysfunction/failure according to SOFA score.

Full Information

First Posted
May 5, 2018
Last Updated
December 9, 2019
Sponsor
University of Pecs
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1. Study Identification

Unique Protocol Identification Number
NCT04195126
Brief Title
Early Haemadsorption in Major Burns
Official Title
Early Haemadsorption Treatment of Major Burn Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pecs

4. Oversight

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

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Multiple Organ Failure, Shock, Organ Dysfunction Syndrome, Multiple, Renal Dysfunction, Cytokine Storm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients included in our study are randomised into treatment or control groups.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcome assessors are unaware of the patient groups. Treated patients are not informed regarding randomisation results.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion).
Intervention Type
Device
Intervention Name(s)
CytoSorb haemadsorption device
Intervention Description
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 Measure Information:
Title
7 days mortality
Description
The investigators assess the intensive care and post-intensive care mortality of our patients.
Time Frame
Survival rate is assessed in the 7th admission day.
Title
28 days mortality
Description
The investigators assess the intensive care and post-intensive care mortality of our patients.
Time Frame
Survival rate is assessed in the 28th admission day.
Secondary Outcome Measure Information:
Title
Levels of inflammatory and anti-inflammatory cytokines during treatment
Description
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.
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.
Title
Markers of oxidative stress (ROS production, MDA levels, tyrosine isomers)
Description
The investigators follow the severity of oxidative stress in both groups.
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.
Title
Intensive Care Unit length of stay
Description
The investigators assessed the duration of ICU stay (in days)
Time Frame
Length of intensive care for each patient (days), data is registered through ICU discharge of the patient, an average of 1 month.
Title
Volume resuscitation fluid need of our patients.
Description
The investigators assess the primary volume resuscitation need of our patients.
Time Frame
Results are summarised daily for our patients during the first week following inclusion.
Title
Vasopressor need of our patients.
Description
The investigators assess the daily average vasopressor dose of our patients.
Time Frame
Results are summarised daily for our patients during the first week following inclusion.
Title
Length of mechanical ventilation (if needed).
Description
The investigators assess whether CytoSorb treatment reduce the length of mechanical ventilation
Time Frame
Length of mechanical ventillation (days). Data is registered through patient discharge from ICU, an average of 1 month.
Title
Severity of organ failures according to SOFA point system
Description
The investigators assess the severity of multiple organ dysfunction/failure according to SOFA score.
Time Frame
Assessed daily for each patient during the first week of our study. Worst results are registered.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gábor Woth, MD PhD
Phone
+36703729231
Email
glwoth@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tamás Kiss, MD PhD
Email
kisstamasmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gábor Woth, MD PhD
Organizational Affiliation
University of Pécs, Dept. of Anaesthesia and Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pécs, Dept. of Anaesthesia and Intensive Care
City
Pécs
State/Province
Baranya County
ZIP/Postal Code
7622
Country
Hungary
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gábor Woth, MD PhD
Phone
+36703729231
Email
woth.gabor@pte.hu
First Name & Middle Initial & Last Name & Degree
Tamás Kiss, MD PHD
Email
kiss.tamas@pte.hu
First Name & Middle Initial & Last Name & Degree
Gábor Woth, MD PhD
First Name & Middle Initial & Last Name & Degree
Bálint Nagy, MD PhD
First Name & Middle Initial & Last Name & Degree
Tamás Kiss, MD PhD
First Name & Middle Initial & Last Name & Degree
Zsófia Kriszta, MD
First Name & Middle Initial & Last Name & Degree
Krisztina Kovács, MD PHD
First Name & Middle Initial & Last Name & Degree
Lajos Bogár, MD PhD Prof
First Name & Middle Initial & Last Name & Degree
Diana Mühl, MD PHD Prof
First Name & Middle Initial & Last Name & Degree
Csaba Csontos, MD PHD

12. IPD Sharing Statement

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

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Early Haemadsorption in Major Burns

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