Early Haemadsorption in Major Burns
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|ClinicalTrials.gov Identifier: NCT04195126|
Recruitment Status : Not yet recruiting
First Posted : December 11, 2019
Last Update Posted : December 11, 2019
|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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.
- 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
- 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.
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
|Contact: Gábor Woth, MD PhDfirstname.lastname@example.org|
|Contact: Tamás Kiss, MD PhDemail@example.com|
|University of Pécs, Dept. of Anaesthesia and Intensive Care|
|Pécs, Baranya County, Hungary, 7622|
|Contact: Gábor Woth, MD PhD +36703729231 firstname.lastname@example.org|
|Contact: Tamás Kiss, MD PHD email@example.com|
|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|
|Principal Investigator:||Gábor Woth, MD PhD||University of Pécs, Dept. of Anaesthesia and Intensive Care|