[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07424625":3,"trial-entities:NCT07424625":135,"trial-summary:NCT07424625":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":51,"sex":90,"minimum_age":91,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":92,"std_ages":104,"locations":107,"central_contacts":124,"overall_officials":127,"references":129,"see_also_links":134},"NCT07424625","25-002104","A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients","THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial","NOT_YET_RECRUITING","2028-06","2026-06","2026-08-03","2026-09","Mayo Clinic","OTHER",false,"The purpose of this research is to determine if two commonly used medications to treat metabolic acidosis in the setting of cardiac surgery, sodium bicarbonate and THAM, are equivalent.",null,[19],"Metabolic Acidosis",[21,22,23,24],"THAM","Sodium bicarbonate","metabolic acidosis","cardiac surgery","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},250,"ESTIMATED",[33,40],{"type":34,"name":22,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Patients in the ICU following cardiothoracic surgery with use of cardiopulmonary bypass and requiring treatment for metabolic acidosis (base excess less than -5), will receive sodium bicarbonate (Bicarb) if randomized to the Bicarb arm.",[37],"Sodium bicarbonate (Bicarb)",[39],"Bicarb",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"Tris-hydroxymethyl Aminomethane","Patients in the ICU following cardiothoracic surgery with use of cardiopulmonary bypass, requiring treatment for metabolic acidosis (base excess less than -5), will receive tris-hydroxymethyl aminomethane (THAM) if randomized to the THAM arm.",[44],"Tris-hydroxymethyl aminomethane (THAM)",[21],[47],{"measure":48,"description":49,"timeFrame":50},"Change in pH following buffer administration","pH will be measured via arterial blood gas test","Baseline, 2 hours",[52,55,58,61,64,67,70,72,74,78,81,84,87],{"measure":53,"description":54,"timeFrame":50},"Change in sodium","Sodium will be measured via blood test and reported in reported in mEq\u002FL (milliequivalents per liter)",{"measure":56,"description":57,"timeFrame":50},"Change in potassium","Potassium will be measured via blood test and reported in reported in mEq\u002FL (milliequivalents per liter)",{"measure":59,"description":60,"timeFrame":50},"Change in lactate","Lactate will be measured via blood test and reported in mmol\u002FL (millimoles per liter)",{"measure":62,"description":63,"timeFrame":50},"Change in (arterial partial pressure of carbon dioxide) PaCO2","PaCO2 will be measured via arterial blood gas test, reported as mmHg (millimeters of mercury)",{"measure":65,"description":66,"timeFrame":50},"Change in cardiac index","Cardiac index is determined by dividing cardiac output by body surface area, with a normal range of 2.5-4.0 L\u002Fmin\u002Fm²",{"measure":68,"description":69,"timeFrame":50},"Change in Mean arterial pressure (MAP)","Mean arterial pressure (MAP) is the average pressure in the arteries throughout one cardiac cycle. Normal MAP is between 70 and 100, reported as mmHg (millimeters of mercury)",{"measure":71,"timeFrame":50},"Change in vasopressor dosing",{"measure":73,"timeFrame":50},"Change in inotrope dose",{"measure":75,"description":76,"timeFrame":77},"Duration of mechanical ventilation","Duration of mechanical ventilation will be reported in hours","7 days",{"measure":79,"description":80,"timeFrame":77},"Incidence of acute kidney injury","Number of patients who develop acute kidney injury",{"measure":82,"description":83,"timeFrame":77},"Incidence of renal replacement therapy","Number of patients who newly require renal replacement therapy",{"measure":85,"description":86,"timeFrame":77},"ICU length of stay","Number of days patient stays in ICU",{"measure":88,"description":89,"timeFrame":77},"Hospital length of stay","Number of days patient is hospitalized","ALL","21 Years",{"inclusion":93,"exclusion":97,"raw_text":103},[94,95,96],"Cardiothoracic surgery with use of cardiopulmonary bypass","Presence of metabolic acidosis (defined as a base excess of \\\u003C-5)","Minnesota Research Authorization",[98,99,100,101,102],"Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass","Absence of metabolic acidosis (metabolic acidosis being defined as a base excess of \\\u003C-5)","Pregnant patients","Prisoners","Opt out of Minnesota Research Authorization","* Inclusion criteria\n\n  * Cardiothoracic surgery with use of cardiopulmonary bypass\n  * Presence of metabolic acidosis (defined as a base excess of \\\u003C-5)\n  * Minnesota Research Authorization\n* Exclusion criteria\n\n  * Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass\n  * Absence of metabolic acidosis (metabolic acidosis being defined as a base excess of \\\u003C-5)\n  * Pregnant patients\n  * Prisoners\n  * Opt out of Minnesota Research Authorization",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":13,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":121},"Rochester","Minnesota","55901","United States",[114,118],{"name":115,"role":116,"phone":117},"Nicole M. Lenort, RRT, LRT","CONTACT","866-265-9263",{"name":119,"role":120},"Misty A. Radosevich, MD","PRINCIPAL_INVESTIGATOR",{"lat":122,"lon":123},44.02163,-92.4699,[125],{"name":115,"role":116,"phone":117,"email":126},"Lenort.Nicole@mayo.edu",[128],{"name":119,"affiliation":13,"role":120},[130],{"pmid":131,"type":132,"citation":133},"37075790","BACKGROUND","Radosevich MA, Wieruszewski PM, Wittwer ED. Tris-Hydroxymethyl Aminomethane in Critically Ill Adults: A Systematic Review. Anesth Analg. 2023 Nov 1;137(5):1007-1018. doi: 10.1213\u002FANE.0000000000006485. Epub 2023 Apr 19.",[],{"nct_id":4,"conditions":136,"biomarkers":138},[137,19],"Cardiac Surgery",[],{"nct_id":4,"found":140,"summary":141,"prompt_version":151},true,{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This interventional study will compare two medications, THAM and sodium bicarbonate, in about 250 participants. Participants will be randomly assigned to receive one of the two medications.","completed","Study of THAM vs. Sodium Bicarbonate for Metabolic Acidosis in Cardiac Surgery","This study is looking at two common medications, Tris-hydroxymethyl Aminomethane (THAM) and sodium bicarbonate, to see if they work similarly to treat metabolic acidosis. Metabolic acidosis is a condition where there's too much acid in your blood. This study is for patients in the intensive care unit (ICU) who have had heart surgery involving a heart-lung machine (cardiopulmonary bypass) and need treatment for metabolic acidosis. Researchers will measure the change in your blood's pH (a measure of acidity) after you receive one of these medications. The study aims to enroll 250 participants, but its current status is unclear.","Your pH will be measured at baseline and 2 hours after receiving the medication.",98,"Participants will receive either sodium bicarbonate or THAM. Your pH will be measured at the start of treatment and again 2 hours later.","Not stated in the trial record.",[22,41],"v2"]