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The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary circuit attenuates the inflammatory response to extracorporeal circulation in patients undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by the CytoSorb device significantly improves circulation and outcome in patients undergoing on-pump cardiac surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With CytoSorb device | Active Comparator | Patients randomised to this arm are treated with the CytoSorb device during bypass. |
|
| Withouot device | No Intervention | Patients randomised to this arm are treated without the CytoSorb device during bypass. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of levels of cytokines during procedure compared to baseline | parameters to be measured are: interleukin (IL) 1, interleukin 6, interleukin 8, interleukin 10, tumor necrosis factor-alpha | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of hemodynamic parameters during procedure compared to baseline | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of administered fluids | The amount of fluids administered during operation is recorded. | at the end of surgery, approximately 3 hours after begin of surgery |
| Amount of administered catecholamines. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens C. Kubitz, MD PhD | Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Study Director |
| Daniel A. Reuter, MD PhD | Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Study Chair |
| Alexander März, MD | Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Principal Investigator |
| Ingo Garau, MD | Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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 |
| Thromboelastometry | 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. | at the end of bypass, approximately 3 hours after begin of surgery |
| Change of cognitive and emotional state in comparison to condition before surgery | 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. | 1)one day before surgery 2) 24 hours after bypass |
The amount of catecholamines administered during operation is recorded.
| at the end of surgery, approximately 3 hours after begin of surgery |
| Amount of administered catecholamines | The amount of catecholamines administered during operation is recorded. | after discharge from ICU, approximately 24 hours after surgery |
| Change of a set of general laboratory parameters during procedure | 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. | 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 |
| Intensive care durations | After discharge from ICU the duration of stay and postoperative ventilation is recorded. | after discharge from ICU, approximately 24 hours after admission |
| complication and adverse events | Any complications or adverse events, like death, bleeding, rethoracotomy or malignant arrhythmias are recorded. | 24 hours after admission to ICU |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |