[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammation-in-cardiac-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammation-in-cardiac-surgery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100615034","phase-4-colchicines-effect-on-inflammatory-markers-100615034",false,"NCT07287345","Colchicine's Effect on Inflammatory Markers","Adjunctive Colchicine's Effect on Inflammatory Markers and Corresponding New-Onset Atrial Fibrillation Rates Post Coronary Artery Bypass Graft Procedure: A Pilot Study","Inclusion Criteria:\n\n* Age 18 years and older\n* Coronary artery bypass graft (CABG) planned procedure\n\nExclusion Criteria:\n\n* History of atrial fibrillation\n* Off-pump CABG procedure\n* Current treatment with colchicine for any cause\n* Hypersensitivity to colchicine (as indicated by rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever)\n* Emergency cardiac surgery\n* Extracorporeal Membrane Oxygenation (ECMO) pre- or post-cardiac surgery\n* Heart transplant patients\n* Left ventricular assist device (LVAD) patients\n* Serum creatinine \\>2.0 mg\u002FdL\n* Preoperative elevated CK or known myopathy\n* Severe liver disease or elevation of serum transaminases (\\>1.5 times the upper limit of 40 units\u002Fliter)\n* Chronic intestinal disease or blood dyscrasia\n* Unable to speak English\n* Pregnancy or lactation in women","ALL","18 Years","99 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study wants to see if the medicine colchicine can help lower inflammation and reduce the chance of developing an irregular heartbeat (atrial fibrillation) after heart bypass surgery. Adults having coronary artery bypass surgery (CABG) can join. Participants will be randomly placed into one of two groups: one group will receive colchicine along with usual care, and the other will receive a placebo (a look-alike capsule with no medicine) along with usual care. Everyone will take a study capsule, and neither the patients nor the study team will know which capsule is being given. Everyone in the study will take study capsule, and neither the patients nor the study team will know who is receiving colchicine or placebo. Blood samples and health information will be collected before surgery; at 24, 48, 72, and 96 hours after surgery; and again at 10 days after surgery or at hospital discharge, whichever comes first. The investigators will look at inflammation marker levels, whether atrial fibrillation happens, and any side effects. This small study will help to generate effect size estimates and safety data that will help plan a larger study in the future.",[27,28,29,30,31],"Colchicine","Inflammation in Cardiac Surgery","Post Operative Atrial Fibrillation","Inflammatory Markers","Colchicine Adverse Reaction","RECRUITING","2026-06-23",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2026-01-16",{"date":40,"type":21},"2026-12-30",{"name":42,"class":43},"Ayesha Ather","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100595791","phase-3-hydrocortisone-plus-fludrocortisone-in-high-risk-patients-undergoing-for-cardiac-surgery-100595791","NCT07037043","Hydrocortisone Plus Fludrocortisone in High-risk Patients Undergoing for Cardiac Surgery","VASOCORT","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Patient at intermediate\u002Fhigh risk (EuroSCORE II \\> 4%).\n* Patient admitted for scheduled cardiac surgery:\n\n  * Coronary artery bypass grafting (CABG).\n  * Aortic valve replacement.\n  * Mitral valve repair or replacement.\n  * Surgery of the aortic root (aortic tube, Bentall procedure, Tirone David procedure, or other).\n  * Combined surgery.\n* Patient undergoing cardiopulmonary bypass (CPB).\n* Informed consent signed by the patient.\n\nExclusion Criteria:\n\n* Endocarditis\n* Off-pump heart surgery\n* Heart transplantation or long-term ventricular assist device (VAD)\n* Emergency surgery: aortic dissection, emergency coronary artery bypass grafting (CABG)\n* Failure to wean from CPB requiring short-term mechanical support (intra-aortic balloon pump, ECMO)\n* Hypothermic surgery\n* History of cardiac surgery\n* Patient on long-term corticosteroid therapy\n* Autoimmune disease or chronic inflammatory condition\n* End-stage renal disease on long-term dialysis\n* Contraindications to the administration of hydrocortisone and\u002For fludrocortisone according to the summary of product characteristics (SmPC)\n* Pregnant or breastfeeding woman\n* Patient under legal protection (guardianship, curators, or judicial safeguard).",{"count":53,"type":21},196,[55],"PHASE3","Cardiac surgery is a high-risk surgery and is associated with a rate of postoperative adverse outcomes. Like many others major surgery, cardiac surgery procedures induce a proinflammatory phase usually counterbalanced with an immunosuppressive phase so the immune response remained balanced.\n\nIn some cases, the immune response might be dysregulated with a more pronounced pro inflammatory state that compromises organ perfusion and with the occurrence of organ failure. From a mechanistic approach, the relationship between organ failure is complex and multifactorial with a high level of proinflammatory cytokines, a decrease in microcirculation, an endothelial dysfunction and an activation of coagulation and over. The clinical expression is an increase in vasopressor exposure and dose, an increase in mortality and in adverse outcomes with a predominance of acute kidney injury.\n\nVarious therapies have been assessed to manage cardiac surgery related sepsis including glucocorticoid therapy. Briefly, two major randomized trials assessed glucocorticoid therapy solely in scheduled cardiac surgery with cardiopulmonary bypass. No clinical benefit was demonstrated in term of reduction in postoperative mortality or adverse outcomes. Since, data support that the selection of patients at risk is crucial to demonstrate such a strategy. Indeed, data support that surprisingly some patients will have a very light immune response reflected by a low pro inflammatory cytokine.\n\nThe hypothesis is that the combination glucocorticoid and fludrocortisone could decrease adverse outcomes in selected patients.",[28],[59],"Control of inflammation in cardiac surgery","2026-06-02",{"date":62,"type":36},"2026-06-03",{"date":64,"type":36},"2025-04-30",{"date":66,"type":21},"2028-06",{"name":68,"class":43},"Centre Hospitalier Universitaire, Amiens"]