[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537589":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":234,"collaborators":236,"id":254,"slug":255,"hasResults":256,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":256,"sex":262,"minAge":263,"maxAge":43,"enrollmentInfo":264,"targetDuration":43,"studyType":267,"phases":268,"briefSummary":270,"conditions":271,"keywords":284,"overallStatus":74,"whyStopped":43,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"GCP-Service International West GmbH","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","Patients will receive 0.20 g fish oil\u002Fkg BW\u002Fd (≙2 mL Omegaven®\u002Fkg BW\u002Fd).",[13],"Drug: Fish Oil",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","Patients will receive 0,9% NaCl in volume 2 mL\u002Fkg BW\u002Fd (placebo).",[19],"Drug: Intravenous 0.9% Sodium Chloride",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fish Oil","Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids.\n\nOmegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose.\n\nEach 100 mL of Omegaven® contains 10 g of fish oil (0.1 g\u002FmL).\n\nTimeframe: Day -1: 0.20 g fish oil\u002Fkg BW\u002Fd (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil\u002Fkg BW\u002Fd; postoperative days 1 to max. 7): 0.20 g fish oil\u002Fkg BW\u002Fd",[9],[27],"Omegaven®",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Intravenous 0.9% Sodium Chloride","Intravenous 0.9% Sodium Chloride (volume 2 mL\u002Fkg BW\u002Fd) provided at the same timepoints as the intervention.",[15],[33],"Saline Infusion",[35],{"name":36,"affiliation":37,"role":38},"Christian Stoppe, Prof. Dr.","Wuerzburg University Hospital","STUDY_DIRECTOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","49-931-20130001",null,"cstoppe@gcp-service.com",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Ellen Dresen, Dr.","+49 931-201 30392","Dresen_E@ukw.de",[50,72,91,109,127,144,162,180,198,216],{"facility":51,"status":52,"city":53,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University Hospital Augsburg","NOT_YET_RECRUITING","Augsburg","Germany","DE",{"type":57,"coordinates":58},"Point",[59,60],10.89851,48.37154,{"lat":60,"lon":59},[63,67,70],{"name":64,"role":41,"phone":65,"phoneExt":43,"email":66},"Philipp Simon, Prof. Dr.","+49 821 400 - 2371","philipp.simon3@uk-augsburg.de",{"name":68,"role":41,"phone":43,"phoneExt":43,"email":69},"Manfred Weiss, Prof. Dr.","Manfred.Weiss@uk-augsburg.de",{"name":64,"role":71,"phone":43,"phoneExt":43,"email":43},"PRINCIPAL_INVESTIGATOR",{"facility":73,"status":74,"city":75,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Charité Universitätsmedizin Berlin","RECRUITING","Berlin",{"type":57,"coordinates":77},[78,79],13.41053,52.52437,{"lat":79,"lon":78},[82,86,89],{"name":83,"role":41,"phone":84,"phoneExt":43,"email":85},"Sascha Ott, M.D","49-30-4593-2600","sascha.ott@dhzc-charite.de",{"name":87,"role":41,"phone":43,"phoneExt":43,"email":88},"Maren Kleine-Brüggeney, M.D","maren.kleine-brueggeney@dhzc-charite.de",{"name":90,"role":71,"phone":43,"phoneExt":43,"email":43},"Sascha Ott, M.D.",{"facility":92,"status":74,"city":93,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"University of Bonn","Bonn",{"type":57,"coordinates":95},[96,97],7.09549,50.73438,{"lat":97,"lon":96},[100,104,107],{"name":101,"role":41,"phone":102,"phoneExt":43,"email":103},"Maria Wittmann, M.D","49-228 287-15074-14137","maria.wittmann@ukbonn.de",{"name":105,"role":41,"phone":43,"phoneExt":43,"email":106},"Florian Piekarski, M.D","Florian.Piekarski@ukbonn.de",{"name":108,"role":71,"phone":43,"phoneExt":43,"email":43},"Maria Wittmann, M.D.",{"facility":110,"status":74,"city":111,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University Hospital Goettingen","Göttingen",{"type":57,"coordinates":113},[114,115],9.93228,51.53443,{"lat":115,"lon":114},[118,122,125],{"name":119,"role":41,"phone":120,"phoneExt":43,"email":121},"Reiner Wäschle, M.D","49-551-3967701","Reiner.Waeschle@med.uni-goettingen.de",{"name":123,"role":41,"phone":43,"phoneExt":43,"email":124},"Anselm Bräuer, M.D.","anselm.braeuer@med.uni-goettingen.de",{"name":126,"role":71,"phone":43,"phoneExt":43,"email":43},"Reiner Waeschle, M.D.",{"facility":128,"status":74,"city":129,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"University Hospital Hamburg-Eppendorf","Hamburg",{"type":57,"coordinates":131},[132,133],9.99302,53.55073,{"lat":133,"lon":132},[136,140,143],{"name":137,"role":41,"phone":138,"phoneExt":43,"email":139},"Bernd Saugel, Prof. Dr.","+49 40 7410-52415","b.saugel@uke.de",{"name":141,"role":41,"phone":43,"phoneExt":43,"email":142},"Ekaterina Nekhaeva, Dr.","e.nekhaeva@uke.de",{"name":137,"role":71,"phone":43,"phoneExt":43,"email":43},{"facility":145,"status":74,"city":146,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"University Medical Center Schleswig-Holstein","Kiel",{"type":57,"coordinates":148},[149,150],10.13489,54.32133,{"lat":150,"lon":149},[153,157,160],{"name":154,"role":41,"phone":155,"phoneExt":43,"email":156},"Radke David, M.D","49-431 - 500 20801","David.Radke@uksh.de",{"name":158,"role":41,"phone":43,"phoneExt":43,"email":159},"Matthias Lindner, M.D","Matthias.Lindner@uksh.de",{"name":161,"role":71,"phone":43,"phoneExt":43,"email":43},"David Radke, M.D.",{"facility":163,"status":74,"city":164,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"University Hospital Mainz","Mainz",{"type":57,"coordinates":166},[167,168],8.28008,49.98185,{"lat":168,"lon":167},[171,175,178],{"name":172,"role":41,"phone":173,"phoneExt":43,"email":174},"Daniel Dürr, Prof. Dr.","+49 6131 17-2106","Daniel.Duerr@unimedizin-mainz.de",{"name":176,"role":41,"phone":43,"phoneExt":43,"email":177},"Jan Beer, Dr.","Jan.Beer@unimedizin-mainz.de",{"name":179,"role":71,"phone":43,"phoneExt":43,"email":43},"Daniel Dürr",{"facility":181,"status":74,"city":182,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"University Hospital Muenster","Münster",{"type":57,"coordinates":184},[185,186],7.62571,51.96236,{"lat":186,"lon":185},[189,193,196],{"name":190,"role":41,"phone":191,"phoneExt":43,"email":192},"Alexander Zarbock, M.D","49-251-83-44017","zarbock@uni-muenster.de",{"name":194,"role":41,"phone":43,"phoneExt":43,"email":195},"Melanie Meersch-Dini, M.D","meersch@ukmuenster.de",{"name":197,"role":71,"phone":43,"phoneExt":43,"email":43},"Alexander Zarbock, M.D.",{"facility":199,"status":52,"city":200,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"University Medical Center Rostock","Rostock",{"type":57,"coordinates":202},[203,204],12.14049,54.0887,{"lat":204,"lon":203},[207,211,215],{"name":208,"role":41,"phone":209,"phoneExt":43,"email":210},"Jens-Christian Schewe, M.D.","49-431-500 20801","Jens-Christian.Schewe@med.uni-rostock.de",{"name":212,"role":41,"phone":213,"phoneExt":43,"email":214},"Benjamin Löser, M.D.","49-381-494 146234","Benjamin.loeser@med.uni-rostock.de",{"name":208,"role":71,"phone":43,"phoneExt":43,"email":43},{"facility":217,"status":52,"city":218,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Robert Bosch Medical Center","Stuttgart",{"type":57,"coordinates":220},[221,222],9.17702,48.78232,{"lat":222,"lon":221},[225,229,233],{"name":226,"role":41,"phone":227,"phoneExt":43,"email":228},"Christian Wunder, M.D.","49-711-8101 3484","christian.wunder@rbk.de",{"name":230,"role":41,"phone":231,"phoneExt":43,"email":232},"Magdalena Rufa, M.D.","49-711-8101 5069","magdalena.rufa@rbk.de",{"name":226,"role":71,"phone":43,"phoneExt":43,"email":43},{"type":235,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[237,240,241,242,244,246,247,249,250,252,253],{"name":238,"class":239},"University Hospital, Bonn","OTHER",{"name":181,"class":239},{"name":110,"class":239},{"name":243,"class":239},"University Hospital Schleswig-Holstein",{"name":245,"class":239},"Charite University, Berlin, Germany",{"name":37,"class":239},{"name":248,"class":239},"Johannes Gutenberg University Mainz",{"name":51,"class":239},{"name":251,"class":239},"Universitätsklinikum Hamburg-Eppendorf",{"name":199,"class":239},{"name":217,"class":239},"100537589","phase-2-intravenous-fish-oil-based-lipid-emulsion-to-enhance-recovery-in-high-risk-cardiac-surgery-patients-100537589",false,"NCT06279793","Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients","Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -","MODIFY CSX","Inclusion Criteria:\n\n1. Written informed consent prior to study participation\n2. Adult patients (≥ 18 years)\n3. Patients scheduled to undergo elective cardiac surgery with the use of CPB, who are defined as high risk based on having (i) one of the following surgical procedures: valvular heart surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and\u002For descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction \\\u003C35%\n\nExclusion Criteria:\n\n1. Known hypersensitivity to fish oil\u002Ffish products or egg protein\n2. Pregnancy or lactation period\n3. Previous history of chronic atrial fibrillation, atrial flutter and\u002For atrial tachyarrhythmia\n4. Inability or unwillingness of individual to give written informed consent\n5. Not expected to survive an additional 48 hours from screening evaluation\n6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated \"Do not Resuscitate\" \\[DNR\\] acceptable)\n7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma\n8. Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)\n9. Enrolment in anyinterventional trial within the last 30 days\n10. Already receiving FO-containing medical nutrition products\n11. Severe malnutrition (as defined by the BMI \\\u003C18.5)\n12. Severe liver dysfunction defined by Child Pugh Class C.\n13. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR \\\u003C30ml\u002Fmin)\n14. Known severe coagulation disorder","ALL","18 Years",{"count":265,"type":266},550,"ESTIMATED","INTERVENTIONAL",[269],"PHASE2","The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.\n\nA total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil\u002Fkg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.",[272,273,274,275,276,277,278,279,280,281,282,283],"Intensive Care Unit","Coronary Artery Bypass Grafting (CABG)","High Risk Patients","Cardiopulmonary Bypass","Elective Cardiac Surgery","Valvular Heart Surgery","Multiple Valve Surgeries","Combined Cardiac Procedures","Aortic Surgical Procedures","Adult Patients ≥ 18 Years","Combined Valve and CABG","Combined Cardiac and Aortic Surgical Procedures",[285,286,287,288,289,290,291],"intensive care unit","elective cardiac surgery","fish oil","medical nutrition therapy","atrial fibrillation","atrial flutter","atrial tachycardia","2026-02-19",{"date":294,"type":295},"2026-02-23","ACTUAL",{"date":297,"type":295},"2024-02-15",{"date":299,"type":266},"2030-09",{"name":5,"class":6},10]