[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625715":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":39,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Hospital Nossa Senhora da Conceicao","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adenosine","ACTIVE_COMPARATOR",null,[13],"Drug: Adenoseine",{"label":15,"type":16,"description":11,"interventionNames":17},"Sterile Distilled Water","PLACEBO_COMPARATOR",[18],"Drug: Placebo (sterile distilled water)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Adenoseine","Participants randomized to the adenosine group will receive a single bolus of adenosine 1.2 mmol\u002FL (24 mg) administered directly into the aortic root immediately after aortic cross-clamping and immediately before infusion of standard del Nido cardioplegia. The solution will be prepared by the perfusionist under sterile conditions.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Placebo (sterile distilled water)","Participants randomized to the placebo group will receive a single bolus of sterile distilled water, matched in volume and appearance to the adenosine solution, administered into the aortic root immediately after aortic cross-clamping and immediately prior to infusion of standard del Nido cardioplegia. The solution will be prepared by the perfusionist under sterile conditions to ensure identical volume and appearance to the placebo solution. Perioperative and postoperative management will be identical to the intervention group.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Felipe Abatti Spadini, MD, MSc","CONTACT","+5554981181291","felipespadini@gmail.com",{"name":36,"role":32,"phone":37,"phoneExt":11,"email":38},"Andre Schimdt, PhD","+555133572000","apschmidt@hcpa.edu.br",[40],{"facility":41,"status":11,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hospital Nossa Senhora da Conceição","Porto Alegre","Rio Grande do Sul","91350-200","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-51.23019,-30.03283,{"lat":51,"lon":50},[54,55,58,60,63,65,66],{"name":31,"role":32,"phone":37,"phoneExt":11,"email":34},{"name":56,"role":32,"phone":37,"phoneExt":11,"email":57},"Adriana Silveira Almeida, PhD","adrianasdealmeida@gmail.com",{"name":31,"role":59,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":61,"role":62,"phone":11,"phoneExt":11,"email":11},"Carolina Zanonato Dutra, MD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":11,"phoneExt":11,"email":11},"Juarez Rode, MD",{"name":56,"role":59,"phone":11,"phoneExt":11,"email":11},{"name":67,"role":59,"phone":11,"phoneExt":11,"email":11},"Andre Prato Schmidt, PhD",{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100625715","phase-4-effect-of-the-addition-of-adenosine-on-myocardial-protection-during-cardiopulmonary-bypass-100625715",false,"NCT07426237","Effect of the Addition of Adenosine on Myocardial Protection During Cardiopulmonary Bypass","Effect of the Addition of Adenosine on Myocardial Protection During Cardiopulmonary Bypass: A Double-Blind Randomized Clinical Trial","ADENOCARDIO","Inclusion Criteria:\n\n* All patients aged 18 years or older undergoing elective isolated valve replacement or coronary artery bypass grafting with cardiopulmonary bypass at Hospital Nossa Senhora da Conceição, Porto Alegre\n\nExclusion Criteria:\n\n* Previous cardiac surgery;\n* Chronic kidney disease (serum creatinine greater than 2.0 mg\u002FdL);\n* Severe psychiatric illness;\n* Urgent or emergency surgery;\n* Multiple cardiac procedures.","ALL","18 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The goal of this clinical trial is to evaluate whether the addition of adenosine to standard cardioplegia improves myocardial protection in adult patients undergoing on-pump cardiac surgery. The study population includes adult patients of both sexes undergoing elective cardiac procedures requiring cardiopulmonary bypass and cardioplegic arrest.\n\nThe main questions this trial aims to answer are:\n\nDoes the addition of adenosine to cardioplegia affect myocardial protection as assessed by transesophageal echocardiography (TEE)?\n\nWhat is the effect of adenosine on biochemical markers of myocardial injury, such as postoperative high-sensitivity troponin levels?\n\nWhat is the effect of adenosine on perioperative hemodynamic support requirements, as quantified by the Vasoactive-Inotropic Score (VIS)?\n\nResearchers will compare patients receiving adenosine-supplemented cardioplegia with those receiving standard cardioplegia (placebo) to assess differences in echocardiographic indicators of myocardial protection, biomarker release, and need for vasoactive\u002Finotropic support.\n\nParticipants will:\n\nReceive either adenosine-supplemented cardioplegia (adenosine 1.2 mmol\u002FL; 24 mg) or placebo according to randomization.\n\nUndergo standard perioperative monitoring during cardiac surgery.\n\nUndergo intraoperative transesophageal echocardiography (TEE) to evaluate myocardial protection by comparing pre- and post-cardiopulmonary bypass (CPB) measurements.\n\nHave postoperative laboratory testing for high-sensitivity troponin at baseline, 2h, 12h, and 24h after clamp release.\n\nHave hemodynamic support requirements recorded and VIS calculated at the end of surgery and at 12h and 24h postoperatively.\n\nBe followed for perioperative clinical outcomes including arrhythmias, need for cardioversion or mechanical circulatory support, ICU\u002Fhospital length of stay, myocardial infarction, and mortality.",[88],"Myocardial Protection",[90,91,92],"myocardial protection","cardioplegia","del Nido","NOT_YET_RECRUITING","2026-02-19",{"date":96,"type":97},"2026-02-23","ACTUAL",{"date":99,"type":82},"2026-03-30",{"date":101,"type":82},"2027-07-01",{"name":5,"class":6},1]