[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552797":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":41,"locations":48,"responsibleParty":76,"collaborators":26,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":107,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University Medical Centre Maribor","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Extracorporeal Circulation Arm (CCPB Arm)","ACTIVE_COMPARATOR","Patients randomized into this group will be undergoing arrested-heart coronary artery bypass grafting with the use of conventional extracorporeal circulation.",[13],"Procedure: Conventional Extracorporeal Circulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Minimally Invasive Extracorporeal Circulation Arm (MiECC Arm)","EXPERIMENTAL","Patients randomized into this group will be undergoing arrested-heart coronary artery bypass grafting with the use of minimally invasive extracorporeal circulation.",[19],"Procedure: Minimally Invasive Extracorporeal Circulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Minimally Invasive Extracorporeal Circulation","Clinical outcomes, oxidative stress marker levels comparison in patients undergoing open-heart surgery with minimally invasive extracorporeal circulation.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Extracorporeal Circulation","Clinical outcomes, oxidative stress marker levels comparison in patients undergoing open-heart surgery with either conventional extracorporeal circulation.",[9],[32,36,39],{"name":33,"affiliation":34,"role":35},"Rene Petrovic, MD","UMC Maribor","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Petra Kotnik, PhD","University of Maribor",{"name":40,"affiliation":34,"role":35},"Miha Antonic, MD, PhD",[42,46],{"name":33,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+38640556570","rene.petrovic@gmail.com",{"name":40,"role":43,"phone":26,"phoneExt":26,"email":47},"miha.antonic@guest.arnes.si",[49],{"facility":34,"status":26,"city":50,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Maribor","Slovenia","SI",{"type":54,"coordinates":55},"Point",[56,57],15.64593,46.55583,{"lat":57,"lon":56},[60,62,63,66,68,70,72,74],{"name":61,"role":43,"phone":44,"phoneExt":26,"email":45},"Rebe Petrovic, MD",{"name":40,"role":43,"phone":26,"phoneExt":26,"email":47},{"name":64,"role":65,"phone":26,"phoneExt":26,"email":26},"Anze Djordjevic, MD, PhD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":26,"phoneExt":26,"email":26},"Jernej Zeleznik, MD",{"name":69,"role":65,"phone":26,"phoneExt":26,"email":26},"Urska Intihar, MD",{"name":71,"role":65,"phone":26,"phoneExt":26,"email":26},"Peter Juric, MD",{"name":73,"role":65,"phone":26,"phoneExt":26,"email":26},"Boris Robic, MD",{"name":75,"role":65,"phone":26,"phoneExt":26,"email":26},"Franc Gregorcic, MD",{"type":35,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Rene Petrovic","Principal Investigator","100552797","inflammatory-response-and-oxidative-stress-in-cardiac-surgery-min-invasive-vs-conventional-extracorporeal-circulation-100552797",false,"NCT06477757","Inflammatory Response and Oxidative Stress in Cardiac Surgery: Min. Invasive vs. Conventional Extracorporeal Circulation","Oxidative Stress and Systemic Inflammatory Response After Cardiac Surgery: Minimally Invasive Extracorporeal Circulation vs. Conventional Extracorporeal Circulation","Inclusion Criteria:\n\n* Patients undergoing elective isolated coronary artery bypass grafting (CABG) with the use of cardio-pulmonary bypass (CPB) through median sternotomy with central cannulation\n\nExclusion Criteria Before Enrollment:\n\n* refusal to participate in the study,\n* pregnant women,\n* patients with previous cardiac surgery (i.e., redo surgery),\n* emergency surgery,\n* patients with known allergy to any drugs used in the study protocol except cefazolin.\n\nExclusion Criteria After Enrollment:\n\n\\- Patients in whom intraoperative transesophageal echocardiogram (TEE) would show an atrial septal defect, where additional procedures would be needed intraoperatively or a conversion from MiECC to conventional extracorporeal circulation would be needed.","ALL","18 Years","99 Years",{"count":90,"type":91},200,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of our research project is to measure and compare oxidative stress markers, and systemic inflammatory response in patients undergoing open heart surgery with either conventional or minimally invasive extracorporeal circulation as well as develop pharmacokinetic profiles of different oxidative stress markers for further research on inflammatory response after open heart surgery. The main questions our study aims to answer are :\n\n* Does the type of extracorporeal circulation affect the levels of different oxidative stress markers?\n* Can preoperative and postoperative oxidative stress marker levels be of prognostic values?\n* Do preoperative and postoperative oxidative stress markers correlate with the clinical outcomes in patients?\n\nResearchers will compare the effect of conventional and minimally invasive extracorporeal circulation on clinical outcomes, oxidative stress marker levels, and systemic inflammatory response.\n\nParticipants will be randomised into two groups (one undergoing arrested-heart surgery with the use of conventional extracorporeal circulation, and the second group undergoing arrested-heart surgery with the use of minimally invasive extracorporeal circulation) and laboratory data, oxidative stress markers, and clinical data will be collected until discharge.",[97,98,99],"Oxidative Stress","Systemic Inflammatory Response Syndrome","Extracorporeal Circulation; Complications",[101,102,103,97,98,104,105,106],"Cardiac Surgery","Minimally invasive extracorporeal circulation","Cardiopulmonary bypass","Oxidative stress biomarkers","Malondialdehyde","Endocan","NOT_YET_RECRUITING","2024-06-25",{"date":110,"type":111},"2024-06-27","ACTUAL",{"date":113,"type":91},"2024-07-29",{"date":115,"type":91},"2026-12-31",{"name":5,"class":6},1]