BurnsNCT04195126
Early Haemadsorption in Major Burns
A study testing CytoSorb haemadsorption device in people with Burns and Multiple Organ Failure, run by University of Pecs at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Multiple Organ Failure, Shock
- What is being tested?
- CytoSorb haemadsorption device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2020to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent of our patient or next of kin,
- TBSA >20% with 2/b depth of burn
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tamás Kiss, MD PhD contact
Hungary1 site
University of Pécs, Dept. of Anaesthesia and Intensive Care
Pécs, Baranya, 7622
Gábor Woth, MD PhD, +36703729231, woth.gabor@pte.hu
Tamás Kiss, MD PHD, kiss.tamas@pte.hu
About this study
Official title: 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).
- Conditions
- Burns, Multiple Organ Failure, Shock, Organ Dysfunction Syndrome, Multiple, Renal Dysfunction, Cytokine Storm
- Being tested
- CytoSorb haemadsorption device
- Medical subject headings
- Burns, Multiple Organ Failure, Shock, Renal Insufficiency, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb haemadsorption deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| Treatment group | Active comparator | Besides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion). Receives: Device: CytoSorb haemadsorption device |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 days mortality
The investigators assess the intensive care and post-intensive care mortality of our patients.
Measured: 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.
Measured: Survival rate is assessed in the 28th admission day.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Assessed daily for each patient during the first week of our study. Worst results are registered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients included in our study are randomised into treatment or control groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gábor Woth, MD PhD, Principal investigator, University of Pécs, Dept. of Anaesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195126
- Sponsor's protocol ID
- 7066 - PTE 2018
- Status last verified
- Dec 2019
- First submitted
- 5 May 2018
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators plan to share patient clinical data and laboratory measurement results following study result publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Haemadsorption Treatment of Major Burn Trauma Patients
- ClinicalTrials.gov ID
- NCT04195126
- Acronym / sponsor ID
- 7066 - PTE 2018
- Conditions
- Burns, Multiple Organ Failure, Shock, Organ Dysfunction Syndrome, Multiple, Renal Dysfunction, Cytokine Storm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients included in our study are randomised into treatment or control groups.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| Treatment group | Active comparator | Device: CytoSorb haemadsorption deviceBesides treatment strategies of the control group, the investigators start early haemadsorption treatment right after patient admission (and inclusion). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent of our patient or next of kin,
- TBSA >20% with 2/b depth of burn
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb haemadsorption deviceCytoSorb (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. | Device | Treatment group |
Primary outcome
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.
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.
7 secondary outcomes
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.
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.
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.
Volume resuscitation fluid need of our patients.
Time frame: Results are summarised daily for our patients during the first week following inclusion.
Vasopressor need of our patients.
Time frame: Results are summarised daily for our patients during the first week following inclusion.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: Undecided. The investigators plan to share patient clinical data and laboratory measurement results following study result publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamás Kiss, MD PhD contact
Gábor Woth, MD PhD principal investigator
University of Pécs, Dept. of Anaesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb haemadsorption device in people with Burns and Multiple Organ Failure, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gábor Woth, MD PhD (+36703729231, glwoth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7 days mortality (time frame: Survival rate is assessed in the 7th admission day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019; AzTrials last refreshed its copy on 1 Nov 2026.