Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT02297334|
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Heart Valve Diseases||Device: CytoSorb device||Not Applicable|
Cardiac surgery with cardiopulmonary bypass (CPB) induces an inflammatory response due to contact of patients' blood with foreign surfaces like tubes or the oxygenator, ischemic-reperfusion injury and surgical trauma. Inflammation is modulated by cytokines, especially, interleukins. The extent of cytokine release is further related to the duration of bypass and the amount of operating field suction. This results in a systemic inflammatory response syndrome (SIRS) with the risk of multiple organ dysfunction (MOD). Also in patients treated with extracorporeal membrane oxygenation (ECMO) an activation of the inflammation system is seen and accompanied with an increase of cytokine levels. The cytokine concentration correlates with the severity of the immune reaction and can be a predictor of the outcome of the patient. As severe SIRS and MOD significantly increase mortality, the attenuation of the inflammatory response is supposed to reduce morbidity and mortality after cardiac surgery.
For adult cardiac surgery and patients who are treated with an extracorporal assist device, a tool for cytokine elimination and attenuation of the inflammatory response seems to be beneficial.
In our study we are going to investigate if the use of the CytoSorb device can improve the outcome of patients undergoing elective coronar artery bypass and heart valve surgery.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||August 2017|
Active Comparator: With CytoSorb device
Patients randomised to this arm are treated with the CytoSorb device during bypass.
Device: CytoSorb device
In 20 patients the CytoSorb device will be installed into the extra corporeal circuit. A blood flow of 400ml/min is provided by an roller pump of the heart lung machine in a parallel stream to the main circulation.
Other Name: polymer beads adsorbent
No Intervention: Withouot device
Patients randomised to this arm are treated without the CytoSorb device during bypass.
- Change of levels of cytokines during procedure compared to baseline [ Time Frame: 1) 5 minutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of bypass, 4) 6 hours after bypass 5) 24 hours after bypass ]parameters to be measured are: interleukin (IL) 1, interleukin 6, interleukin 8, interleukin 10, tumor necrosis factor-alpha
- Change of hemodynamic parameters during procedure compared to baseline [ Time Frame: 1) 5 kinutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of bypass, 4) 6 hours after bypass 5) 24 hours after bypass ]Hemodynamic and respiratory parameters such as mean arterial pressure, heart rate and peripheral oxygen saturation are recorded. In addition thermodilution parameters (stroke volume variability, global end diastole volume, extravascular lung water index, cardiac index, systemic vascular resistance) are measured. Volume and catecholamine therapies are managed by an algorithm based on thermodilution parameters.
- Thromboelastometry [ Time Frame: at the end of bypass, approximately 3 hours after begin of surgery ]At the end of extracorporeal circulation a rotation thromboelastometry analysis is performed and the clotting time (CT), the clot formation time (CFT), the maximum clot firmness (MCF) in In- and Ex-Tem and the MCF in Fib-Tem are measured. Based on an institutional algorithm the coagulation therapy is performed according to the results of the thromboelastometry.
- Change of cognitive and emotional state in comparison to condition before surgery [ Time Frame: 1)one day before surgery 2) 24 hours after bypass ]To evaluate, if the use of the cytokine-filter has any influence on cognitive function or the emotional state, the patients perform the mini-mental state examination and answer questions of the Geriatric Depression Scale questionaire. Results before and 24 hours after end of bypass are recorded.
- Amount of administered fluids [ Time Frame: at the end of surgery, approximately 3 hours after begin of surgery ]The amount of fluids administered during operation is recorded.
- Amount of administered catecholamines. [ Time Frame: at the end of surgery, approximately 3 hours after begin of surgery ]The amount of catecholamines administered during operation is recorded.
- Amount of administered catecholamines [ Time Frame: after discharge from ICU, approximately 24 hours after surgery ]The amount of catecholamines administered during operation is recorded.
- Change of a set of general laboratory parameters during procedure [ Time Frame: 1) 5 minutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of surgery 4) 6 hours after bypass 5) 24 hours after bypass ]In laboratory tests we measure the whole blood count (red blood cells, white blood cells, thrombocytes), C-reactive protein, liver enzymes (GOT, GPT), kidney parameters (creatinine, glomerular filtration rate) and electrolytes (sodium, potassium, calcium) are measured.
- Intensive care durations [ Time Frame: after discharge from ICU, approximately 24 hours after admission ]After discharge from ICU the duration of stay and postoperative ventilation is recorded.
- complication and adverse events [ Time Frame: 24 hours after admission to ICU ]Any complications or adverse events, like death, bleeding, rethoracotomy or malignant arrhythmias are recorded.
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): NCT02297334
|Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg|
|Hamburg, Germany, 20246|
|Study Director:||Jens C. Kubitz, MD PhD||Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg|
|Study Chair:||Daniel A. Reuter, MD PhD||Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg|
|Principal Investigator:||Alexander März, MD|
|Principal Investigator:||Ingo Garau, MD|