Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-04-19 @ 1:26 AM
Study NCT ID:
NCT02297334
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2014-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-28', 'studyFirstSubmitDate': '2014-10-08', 'studyFirstSubmitQcDate': '2014-11-18', 'lastUpdatePostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Amount of administered fluids', 'timeFrame': 'at the end of surgery, approximately 3 hours after begin of surgery', 'description': 'The amount of fluids administered during operation is recorded.'}, {'measure': 'Amount of administered catecholamines.', 'timeFrame': 'at the end of surgery, approximately 3 hours after begin of surgery', 'description': 'The amount of catecholamines administered during operation is recorded.'}, {'measure': 'Amount of administered catecholamines', 'timeFrame': 'after discharge from ICU, approximately 24 hours after surgery', 'description': 'The amount of catecholamines administered during operation is recorded.'}, {'measure': 'Change of a set of general laboratory parameters during procedure', 'timeFrame': '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', 'description': '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.'}, {'measure': 'Intensive care durations', 'timeFrame': 'after discharge from ICU, approximately 24 hours after admission', 'description': 'After discharge from ICU the duration of stay and postoperative ventilation is recorded.'}, {'measure': 'complication and adverse events', 'timeFrame': '24 hours after admission to ICU', 'description': 'Any complications or adverse events, like death, bleeding, rethoracotomy or malignant arrhythmias are recorded.'}], 'primaryOutcomes': [{'measure': 'Change of levels of cytokines during procedure compared to baseline', 'timeFrame': '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', 'description': 'parameters to be measured are: interleukin (IL) 1, interleukin 6, interleukin 8, interleukin 10, tumor necrosis factor-alpha'}], 'secondaryOutcomes': [{'measure': 'Change of hemodynamic parameters during procedure compared to baseline', 'timeFrame': '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', 'description': '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': 'Thromboelastometry', 'timeFrame': 'at the end of bypass, approximately 3 hours after begin of surgery', 'description': '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.'}, {'measure': 'Change of cognitive and emotional state in comparison to condition before surgery', 'timeFrame': '1)one day before surgery 2) 24 hours after bypass', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CytoSorb(TM)', 'cytokines', 'inflammation', 'cardiac surgery', 'extracorporeal bypass'], 'conditions': ['Coronary Artery Disease', 'Heart Valve Diseases']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nFor 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing elective coronar bypass AND heart valve surgery\n* expected duration of bypass more than 120 min\n\nExclusion Criteria:\n\n* age under 18 years of age\n* pregnancy\n* medication that interacts with the immune system (e.g. steroids, immune suppressors)\n* patients with diagnosed immunodeficiency (e.g. HIV/AIDS)\n* heparin induced thrombocytopenia type II\n* patients that decline participation'}, 'identificationModule': {'nctId': 'NCT02297334', 'briefTitle': 'Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis', 'orgStudyIdInfo': {'id': 'ANA-UKE-PV 4420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With CytoSorb device', 'description': 'Patients randomised to this arm are treated with the CytoSorb device during bypass.', 'interventionNames': ['Device: CytoSorb device']}, {'type': 'NO_INTERVENTION', 'label': 'Withouot device', 'description': 'Patients randomised to this arm are treated without the CytoSorb device during bypass.'}], 'interventions': [{'name': 'CytoSorb device', 'type': 'DEVICE', 'otherNames': ['polymer beads adsorbent'], 'description': '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.', 'armGroupLabels': ['With CytoSorb device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Jens C. Kubitz, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg'}, {'name': 'Daniel A. Reuter, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg'}, {'name': 'Alexander März, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg'}, {'name': 'Ingo Garau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology Center of Anaesthesiology and Intensive Care Medicine University Medical Center Hamburg-Eppendorf University of Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}