[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-surgery":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100577629","prolonged-chest-tube-treatment-to-reduce-rates-of-atrial-fibrillation-following-cardiac-surgery-100577629",false,"NCT06800781","Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery","Prolonged Posterior Pericardial Chest Tube Treatment to Reduce Rates of Postoperative Atrial Fibrillation Following Cardiac Surgery","PROPER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing non-emergent surgery (\\>24 hours between decision to operate and surgical procedure) with coronary artery bypass grafting, aortic valve replacement, aortic surgery without the use of circulatory arrest, or any combination of these procedures\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* History of atrial fibrillation (AF) or atrial flutter\n* History of electrophysiological interventions or treatment with antiarrhythmic drugs due to arrhythmias other than AF\n* Pre- or postoperative prophylactic treatment with amiodarone\n* Existing pacemaker, ICD, or CRT device without a functional atrial lead\n* Aortic surgery with hypothermic circulatory arrest\n* Previous cardiac surgery\n* Previous radiation of the chest due to malignancy\n* Ongoing infection at time of surgery\n* Ongoing treatment with immunosuppressants, including oral corticosteroids\n* Patient already included in another interventional clinical trial\n* Patient listed abroad, which would render them to be lost to follow-up after discharge\n* Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators.","ALL","18 Years",{"count":20,"type":21},624,"ESTIMATED","INTERVENTIONAL",[24],"NA","Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%. Although it cannot be generalized due to trial undersizing, posterior pericardial chest tube treatment may be a superior alternative to pericardiotomy, given its low risk of procedural complications.\n\nThis interventional multicenter trial will assess whether prolonged treatment with a posterior pericardial chest tube lowers POAF rates after cardiac surgery. Investigators will randomize 624 patients undergoing routine cardiac surgery at Nordic sites 1:1 to receive a posterior pericardial chest tube as adjunct to standard care for up to 3 postoperative days or standard care alone. The primary outcome is the proportion of patients with POAF up to 7 days post-surgery; the study will be powered to detect a relative risk reduction of 30% in the intervention arm. Secondary outcomes are AF burden; days with chest tubes and their output; proportion of patients with POAF up to 14 days post-surgery; direct current conversions during hospital admission; length of ICU\u002Fhospital stay; postoperative complications, mortality, ischemic stroke, and major bleeding at 30\u002F90 days and 1\u002F3\u002F5 years; and quality of life\u002Fpostoperative recovery at 90 days and 1 year. This trial may provide quality clinical evidence supporting the adoption of a simple method to prevent POAF, thus reducing healthcare costs.",[27,28,29],"Coronary Arterial Disease (CAD)","Valve Replacement","Aortic Surgery",[31,32],"Posterior pericardial chest tube","Postoperative atrial fibrillation (POAF)","RECRUITING","2026-04-28",{"date":36,"type":37},"2026-04-29","ACTUAL",{"date":39,"type":37},"2025-02-10",{"date":41,"type":21},"2033-12",{"name":43,"class":44},"Region Skane","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100613470","phase-2-clindamycin-as-an-alternative-to-vancomycin-in-patients-undergoing-aortic-cardiac-surgery-with-extracorporeal-circulation-ecc-100613470","NCT07267013","Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)","Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC): a Prospective Single-center Pharmacokinetic Study","CLINDAPASS","Inclusion Criteria:\n\n* Adult ≥ 18 years of age,\n* Cardiac surgery under ECC\n* Surgery scheduled in the morning (added to the schedule at least 24 hours before the operation and starting at 8 a.m. in order to send blood tests during working hours).\n* Written, informed consent from the patient before the start of the protocol.\n* The patient must understand spoken and written French\n* Negative pregnancy test and effective contraception (according to CTFG recommendations) during treatment for women of childbearing age\n* Men of reproductive age using effective contraception (according to CTFG recommendations) during treatment\n* Social security affiliation\n* Patient able to understand the objectives of the study and comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Known hypersensitivity\u002Fallergy to clindamycin, lincomycin, and any other excipient listed in the SmPC\n* Known hypersensitivity\u002Fallergy to penicillins\u002Fdrugs of the beta-lactam family\n* Patient on antibiotics other than cefazolin prior to surgery\n* Patient already on clindamycin at inclusion,\n* BMI\\>35\n* Aortic arch surgery\n* Coronary artery bypass graft surgery\n* Surgery for suspected endocarditis\n* Patients with chronic renal failure with creatinine clearance \\\u003C 60 mL\u002Fmin and\u002For undergoing chronic dialysis\n* Patients with hepatic insufficiency (prothrombin rate\\\u003C50% excluding anticoagulant therapy) or Child B and C cirrhosis\n* Immunosuppressed patients receiving triple antiviral therapy\n* Pregnant or breast-feeding women\n* Women or men of childbearing age without effective contraception\n* Serious, uncontrolled concomitant bacterial infections (e.g. septic shock)\n* Patients deprived of their liberty by judicial or administrative decision (guardianship, curatorship, safeguard of justice)\n* Patient not registered with social security\n* Participation in any other therapeutic study with an exclusion period still in effect at the time of inclusion, or planned participation in another therapeutic study while taking clindamycin\n* Contraindications to cefazolin or any of the ancillary treatments\n* Mental state rendering the patient incapable of understanding the entire study\n* Patient being the investigator or any other member of the research team or being a relative of the investigator directly involved in the trial, including assistant physicians, pharmacists, nurses, and study coordinators",{"count":55,"type":21},25,[57],"PHASE2","Antibiotic prophylaxis is essential for all types of cardiac surgery under Extracorporeal Circulation (ECC), in order to reduce the incidence of surgical site infection (SSI). However, many patients are allergic to beta-lactam antibiotics. All the more, vancomycin antibiotic recommended as replacement is not without adverse effects and frequently administered in an inappropriate manner in terms of pre-intervention timing, linked to its complex use on peripheral venous lines complicated by venotoxicity. Non-compliance with the correct use of antibiotic prophylaxis in surgery is responsible for nosocomial infections, which have an impact on both the patient and the healthcare establishment in terms of costs, particularly in cardiac surgery.\n\nDrug pharmacokinetics are more complex under bypass surgery (high volume of distribution), and studies are needed to determine the correct administration and diffusion of drugs.\n\nIn this respect, clindamycin is an antibiotic already used in antibiotic prophylaxis for other surgeries (thoracic, orthopedic...) in cases of allergy to beta-lactam antibiotics, but to date there are no studies examining the pharmacokinetics of this molecule in the context of cardiac surgery under ECC.\n\nThe aim of this protocol is to demonstrate the feasibility of using clindamycin in patients undergoing ECC surgery, by verifying that the plasma concentration of clindamycin exceeds the minimum inhibition concentration (MIC) of the main bacteria involved in mediastinitis throughout the surgical procedure.",[29,60],"Extracorporeal Circulation",[62,63,64],"clindamycin","extracorporeal circulation (EEC)","antibiotics","2026-04-27",{"date":34,"type":37},{"date":68,"type":37},"2026-04-21",{"date":70,"type":21},"2026-10-21",{"name":72,"class":44},"Nantes University Hospital"]