[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536846":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":23,"responsibleParty":39,"collaborators":41,"id":48,"slug":23,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":23,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":23,"enrollmentInfo":56,"targetDuration":23,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":72,"whyStopped":23,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":23},{"fullName":5,"class":6},"McMaster University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lower dialysate bicarbonate concentration (32 versus mmol\u002FL)","ACTIVE_COMPARATOR","Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of 32 mmol\u002FL.",[13],"Other: Bicarbonate",{"label":15,"type":10,"description":16,"interventionNames":17},"Higher dialysate bicarbonate concentration (38 mmol\u002FL)","Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of 38 mmol\u002FL.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Bicarbonate","Bicarbonate is added to hemodialysis fluids to correct the metabolic acidosis that arises from kidney failure. Some dialysis units in Canada add bicarbonate to a level of 32 mmol\u002FL, while other units add bicarbonate to a level of 38 mmol\u002FL. It is unknown whether one level is better for people's health.",[15,9],null,[25],{"name":26,"affiliation":27,"role":28},"Amit Garg, MD","LHSC","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Amber Molnar, MD","CONTACT","(905) 522-1155","33787","amolnar@stjosham.on.ca",{"name":26,"role":32,"phone":37,"phoneExt":23,"email":38},"519-685-8502","Amit.Garg@lhsc.on.ca",{"type":40,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[42,45],{"name":43,"class":44},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":46,"class":47},"ACT","UNKNOWN","100536846",false,"NCT06270134","Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate","Dial-Bicarb Trial: Effects of a Lower vs. Higher Concentration of Dialysate Bicarbonate for People Receiving Maintenance Hemodialysis","Inclusion Criteria:\n\n* The dialysis centre director and all nephrologists who provide care in the centre agree to trial participation.\n* Adult patients 18 years of age and older, with a health card number, enter the trial after they receive hemodialysis for at least 90 days (about 3 months) so that patients with acute kidney injury who recover kidney function are excluded.\n\nExclusion Criteria:\n\n\\- Participating centres are instructed that patients on in-centre nocturnal hemodialysis or in-centre frequent (greater than four times weekly) hemodialysis are not in the trial (and do not receive the allocated intervention), since these patients usually receive dialysate bicarbonate concentrations ≤32mmol\u002FL as standard care (based on Ontario registry data, these modalities represent \\\u003C5% of the hemodialysis patient population).","ALL","18 Years",{"count":57,"type":58},14000,"ESTIMATED","INTERVENTIONAL",[61],"NA","This is a pragmatic, two-arm, parallel-group, open-label, individual-randomized, superiority trial that will be conducted in hemodialysis units across Ontario. Patients at each dialysis unit will be randomly allocated into one of two study arms in a 1:1 ratio to receive a dialysate bicarbonate concentration of either 32 or 38 mmol\u002FL. The intervention will be embedded into routine care and delivered by hemodialysis unit personnel.",[64,65],"Renal Failure","Hemodialysis",[67,68,69,70,71],"bicarbonate","renal failure","kidney","pragmatic trial","maintenance hemodialysis","NOT_YET_RECRUITING","2025-03-17",{"date":75,"type":76},"2025-03-20","ACTUAL",{"date":78,"type":58},"2025-04",{"date":80,"type":58},"2029-04",{"name":5,"class":6}]