[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613511":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":48,"locations":54,"responsibleParty":68,"collaborators":34,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":34,"enrollmentInfo":80,"targetDuration":34,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":57,"whyStopped":34,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Region Skane","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Ringer's Acetate 80","ACTIVE_COMPARATOR","Ringer's Acetate 1100 ml with addition of 80 mmol NaCl",[13],"Diagnostic Test: Ringer's Acetate 80",{"label":15,"type":10,"description":16,"interventionNames":17},"Plasmalyte","Plasmalyte 1100 ml, no addition",[18],"Diagnostic Test: Plasmalyte",{"label":20,"type":10,"description":21,"interventionNames":22},"Ringer's Acetate no add","Ringer's Acetate 1100 ml, no addition",[23],"Diagnostic Test: Ringer's Acetate no add",{"label":25,"type":10,"description":26,"interventionNames":27},"Ringer's Acetate 160","Ringer's Acetate with addition of 160 mmol NaCl",[28],"Diagnostic Test: Ringer's Acetate 160",[30,35,38,41],{"type":31,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"DIAGNOSTIC_TEST","Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 80 mmol NaCl",[9],null,{"type":31,"name":15,"description":36,"armGroupLabels":37,"otherNames":34},"Cardiopulmonary bypass circuit will be primed with Plasmalyte 1100 ml, no addition.",[15],{"type":31,"name":20,"description":39,"armGroupLabels":40,"otherNames":34},"Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml no addition",[20],{"type":31,"name":25,"description":42,"armGroupLabels":43,"otherNames":34},"Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 160 mmol NaCl",[25],[45],{"name":46,"affiliation":5,"role":47},"Snejana Hyllén, Phd,MD","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":34,"email":53},"Snejana Hyllén, PhD","CONTACT","+46 763131231","snejana.hyllen@skane.se",[55],{"facility":56,"status":57,"city":58,"state":34,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":34},"Skane University hospital","RECRUITING","Lund","22185","Sweden","SE",{"type":63,"coordinates":64},"Point",[65,66],13.19321,55.70584,{"lat":66,"lon":65},{"type":69,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100613511","heart-lung-machine-impact-of-the-priming-solution-on-acid-base-balance-electrolytes-and-outcome-on-patients-undergoing-cardiac-surgery-100613511",false,"NCT07267546","Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery","Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)","PRIMEII","Inclusion Criteria:\n\n* Patients 18 years and above\n* Undergoing coronary artery bypass graft (CABG) surgery as single surgery\n* Undergoing aortic valve replacement (AVR) as single surgery (AtriClip is allowed)\n* Given consent to participate, both verbal and written\n\nExclusion Criteria:\n\n* Subnormal heart function (defined as an ejection fraction \\\u003C45%), and no signs of heart failure (edema).\n* Body weight \\\u003C60 kg or \\>120 kg\n* Preoperative hemoglobin \\\u003C120 g\u002FL,\n* Subnormal kidney function (defined as GFR \\\u003C30 ml\u002Fmin),\n* Blood sodium outside normal range (135-145 mmol\u002Fl),\n* Need of acute surgery\n* AVR due to aortic valve insufficiency\n* Changes in operating method or addition of intraoperative procedures.","ALL","18 Years",{"count":81,"type":82},80,"ESTIMATED","INTERVENTIONAL",[85],"NA","Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.\n\nThe body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:\n\nHow do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?\n\nThere will be 4 different groups:\n\n1. Ringer-Acetate, 1100 mL \u002F no addition\n2. Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl)\n3. Ringer-Acetate, 1100 mL + 160 mmol NaCl\n4. Plasmalyte, 1100 mL \u002F no addition Blood samples will be taken before, during and after surgery, post operative day 1 and 4 to analyze acid-base balance, electrolytes, and plasma osmolality. Urine output and hydration status will also be collected until post operative day 1. After 3 months, a blood sample will be taken for analysis of electrolytes and kidney function.",[88,89,90,91,92],"Acid Base Imbalance","Osmolality Disturbance","Crystalloid Solutions","Electrolyte Changes","Cardiopulmonary Bypass",[94,95,96,97,98],"cardiopulmonary bypass","priming solution","acid base balance","electrolytes","plasma osmolality","2025-12-04",{"date":101,"type":102},"2025-12-05","ACTUAL",{"date":104,"type":102},"2025-09-01",{"date":106,"type":82},"2026-11-01",{"name":5,"class":6},1]