[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501814":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Lower dialysate bicarbonate","EXPERIMENTAL","A lower dialysate bicarbonate will be used in the experimental arm (30 mEq\u002FL).",[13,14],"Drug: Dialysate bicarbonate concentration","Device: Dialysate bicarbonate concentration - telemetry monitoring",{"label":16,"type":17,"description":18,"interventionNames":19},"Higher dialysate bicarbonate","ACTIVE_COMPARATOR","A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq\u002FL).",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dialysate bicarbonate concentration","Assess how a lower dialysate bicarbonate affects:\n\n* QTc duration during and between hemodialysis sessions\n* PVC burden during and between hemodialysis sessions\n* Clinically significant arrhythmia during and between hemodialysis sessions\n* Intradialytic hypotension\n* Adverse symptoms during hemodialysis sessions",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DEVICE","Dialysate bicarbonate concentration - telemetry monitoring","Patients will be monitored with telemetry on both arms of the trial.",[16,9],[33],{"name":34,"affiliation":5,"role":35},"Katherine S Ravi, MD, MPH","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","(617) 732-6383","ksravi@bwh.harvard.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.05977,42.35843,{"lat":53,"lon":52},[56],{"name":34,"role":38,"phone":57,"phoneExt":26,"email":26},"617-732-6383",{"type":35,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Katherine Scovner Ravi, MD, MPH","Instructor Harvard Medical School \u002F Associate Physician Renal Division","100501814","trial-of-variable-dialysate-bicarbonate-100501814",false,"NCT05814146","Trial of Variable Dialysate Bicarbonate","Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients","Inclusion Criteria:\n\n* prevalent end-stage renal disease, on maintenance HD \\> 90 days\n* age ≥ 18 years old\n* thrice weekly HD\n\nExclusion Criteria:\n\n* hemoglobin \\\u003C 8.0 g\u002FdL\n* pregnancy\n* any physical, mental or medical condition which limited the ability to provide written informed consent","ALL","18 Years","120 Years",{"count":72,"type":73},141,"ESTIMATED","INTERVENTIONAL",[76],"NA","QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death.\n\nIt is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions.\n\nThis study aims to assess the effects of lower (30 mEq\u002FL) versus higher (35 mEq\u002FL) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital.\n\nThe investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.",[79,80,81,82,83],"Peri-dialytic Cardiac Rhythms","Intradialytic Hypotension","Electrolyte Changes","pH Changes","Adverse Symptoms","2025-11-19",{"date":86,"type":87},"2025-11-24","ACTUAL",{"date":89,"type":87},"2023-08-24",{"date":91,"type":73},"2026-10-01",{"name":5,"class":6},1]