[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645632":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":45,"locations":54,"responsibleParty":74,"collaborators":24,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":24,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":105,"whyStopped":24,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Sfax","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Sodium Bicarbonate Arm","EXPERIMENTAL","Adult chronic hemodialysis patients with metabolic acidosis (serum\u002Fplasma bicarbonate \\\u003C 22 mmol\u002FL) randomized to receive oral sodium bicarbonate supplementation according to a stepwise dosing algorithm based on weekly predialysis serum bicarbonate (\"reserves alcalines\").",[13],"Dietary Supplement: Oral sodium bicarbonate",{"label":15,"type":16,"description":17,"interventionNames":18},"Increased Dialysate Bicarbonate Arm","ACTIVE_COMPARATOR","Adult chronic hemodialysis patients with metabolic acidosis (serum\u002Fplasma bicarbonate \\\u003C 22 mmol\u002FL) randomized to receive an increased dialysate bicarbonate concentration according to a predefined stepwise algorithm based on weekly predialysis serum bicarbonate (\"reserves alcalines\" or \"alkaline reserves\" in local laboratory reports).",[19],"Other: Increased Dialysate Bicarbonate",{"label":21,"type":22,"description":23,"interventionNames":24},"Non-Acidotic Hemodialysis Control Group","NO_INTERVENTION","Adult chronic hemodialysis patients with stable, adequate predialysis serum (or plasma) bicarbonate concentrations (so-called \"reserves alcalines\" or \"alkaline reserves\" in local laboratory reports), who are not acidotic according to the study definition, will be included as a non-randomized observational control group. These patients will continue their usual dialysis prescription and routine care without any specific study-mandated change in oral bicarbonate or dialysate bicarbonate. They will be followed over the same 6-week period with collection of serum bicarbonate, sodium, potassium, dialysis adequacy (Kt\u002FV and online clearance monitoring), blood pressure, interdialytic weight gain, and intradialytic symptoms, to provide descriptive reference data on acid-base status, dialysis adequacy, and tolerance in non-acidotic hemodialysis patients",null,[26,33],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIETARY_SUPPLEMENT","Oral sodium bicarbonate","Oral sodium bicarbonate given as Bicardis 500 mg capsules, used as a dietary supplement in Tunisia, administered according to a standardized algorithm based on predialysis serum bicarbonate concentrations, so-called \"reserves alcalines\" in local laboratory reports. At baseline, an initial dose is prescribed according to the severity of metabolic acidosis: 1 capsule\u002Fday if 20-21.9, 2 capsules\u002Fday if 18-19.9, 3 capsules\u002Fday if 16-17.9, 4 capsules\u002Fday if \\\u003C16 mmol\u002FL. At each weekly visit, the same dose is maintained if reserves alcalines remain below the target range and the weekly increase is ≤ 3 mmol\u002FL; the dose is reduced to the previous lower level if the weekly increase is \\> 3 mmol\u002FL or if predialysis bicarbonate enters the predefined target range (22-24 mmol\u002FL); oral bicarbonate is reduced or stopped if predialysis bicarbonate exceeds the upper limit of the target range (\\> 24 mmol\u002FL) to avoid alkalosis, and the dose is increased if reserves alcalines do not improve or decrease.",[9],[32],"Bicardis",{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Increased Dialysate Bicarbonate","Adjustment of the dialysate bicarbonate concentration will be performed according to a standardized titration strategy based on predialysis serum bicarbonate concentrations (\"reserves alcalines\" in local laboratory reports). At baseline, an initial increase in dialysate bicarbonate is prescribed according to the severity of metabolic acidosis: +1 mmol\u002FL if serum bicarbonate is 20-21.9 mmol\u002FL, +2 mmol\u002FL if 18-19.9 mmol\u002FL, +3 mmol\u002FL if 16-17.9 mmol\u002FL, and a larger or individualized increase if \\\u003C 16 mmol\u002FL.\n\nAt each weekly visit, dialysate bicarbonate is then adjusted as follows: it is maintained if reserves alcalines remain below the target range and the weekly increase is ≤ 3 mmol\u002FL; it is reduced to the previous lower level if the weekly increase is \\> 3 mmol\u002FL or if predialysis bicarbonate enters the predefined target range (22-24 mmol\u002FL); and it is reduced or returned to the standard level if predialysis bicarbonate exceeds the upper limit of the target range (\\> 24 mmol\u002FL).",[15],[38,42],{"name":39,"affiliation":40,"role":41},"Lobna Ben Mahmoud, MD, PhD, Professor","University of Sfax, Faculty of medecine of Sfax","STUDY_DIRECTOR",{"name":43,"affiliation":40,"role":44},"Ahmed Hakim, MD, Professor","STUDY_CHAIR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},"Azza KHEDHIRI, MD","CONTACT","+21623146019","ik4m23@gmail.com",{"name":39,"role":48,"phone":52,"phoneExt":24,"email":53},"+21696365092","benmahmoud_lobna@medecinesfax.org",[55],{"facility":56,"status":24,"city":57,"state":24,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Social security fund polyclinic","Sfax","3080","Tunisia","TN",{"type":62,"coordinates":63},"Point",[64,65],10.76028,34.74056,{"lat":65,"lon":64},[68,71,72],{"name":47,"role":48,"phone":69,"phoneExt":70,"email":50},"23146019","+216",{"name":39,"role":48,"phone":52,"phoneExt":24,"email":53},{"name":47,"role":73,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Azza KHEDHIRI","Principal investigator, Head of the Hemodialysis Department of the Sfax Social Security fund polyclinic","100645632","pilot-trial-of-oral-sodium-bicarbonate-versus-higher-dialysate-bicarbonate-in-hemodialysis-patients-with-metabolic-acidosis-100645632",false,"NCT07688434","Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patients With Metabolic Acidosis","Comparative Pilot Trial of Oral Sodium Bicarbonate Versus Increased Dialysate Bicarbonate in Chronic Hemodialysis Patients With Metabolic Acidosis","Bicarbonate-HD","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Stable hemodialysis prescription: 3 times a week, high-flux dialyzers, no major change in dialysis prescription in the previous weeks.\n* Predialysis low \"alkaline reserves\" (serum bicarbonate concentration) according to the operational threshold used in the unit (e.g., \"alkaline reserves\" \\\u003C 22 mmol\u002FL), consistent with KDIGO 2017 definition of metabolic acidosis.\n* Ability to give written informed consent.\n\nFor the observational group:\n\n* Age ≥ 18 years.\n* Chronic hemodialysis for at least 3 months.\n* Hemodialysis 3 times a week, high-flux dialyzers.\n* Predialysis \"alkaline reserves\" considered stable and within the locally defined normal range (≥ 22mmol\u002FL).\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* Recent hemodynamic instability (e.g., repeated intradialytic hypotension or unstable blood pressure in the previous weeks).\n* Recent hospitalization for an acute condition.\n* Acute infection or major intercurrent acute event at the time of screening.\n* Major change in dialysis prescription in the 2 weeks prior to inclusion (e.g., change in dialysis schedule, duration, or dialysate composition outside the study protocol).\n* Severe digestive disorders limiting oral intake (e.g., persistent vomiting, severe malabsorption, or any condition preventing safe oral Bicardis administration).\n* Known hypernatremia or high risk of uncontrolled sodium and fluid overload (as judged by the investigator).\n* Severe uncontrolled hypercalcemia or hypocalcemia.\n* Any condition that, in the investigator's judgment, would preclude safe participation or interfere with study procedures (e.g., very limited life expectancy, inability to attend scheduled visits).\n* Refusal to participate or inability to provide written informed consent.","ALL","18 Years",{"count":88,"type":89},37,"ESTIMATED","INTERVENTIONAL",[92],"NA","Metabolic acidosis is frequent in chronic hemodialysis patients and is associated with adverse clinical outcomes. Two commonly used strategies to correct acidosis are oral sodium bicarbonate supplementation and increasing the bicarbonate concentration of the dialysate, but their comparative effectiveness and tolerance in routine care remain uncertain. This pilot, prospective, randomized, open-label, single-center trial will compare oral sodium bicarbonate versus higher dialysate bicarbonate in chronic hemodialysis patients with metabolic acidosis, using predialysis plasma bicarbonate concentrations, so-called \"reserves alcalines\" or \"alkaline reserves\" in local laboratory reports, as a pragmatic marker of acid-base status.\n\nApproximately 30 acidotic patients (serum bicarbonate \\\u003C 22 mmol\u002FL) will be randomized 1:1 to receive either oral sodium bicarbonate or an increase in dialysate bicarbonate for 6 weeks. An additional non-acidotic observational group will provide descriptive reference data. The primary outcome is the change in predialysis serum bicarbonate from baseline (Day 0) to Day 42 between the two randomized arms. Secondary outcomes include the proportion of patients reaching target serum bicarbonate levels, the weekly kinetics of correction, dialysis adequacy (Kt\u002FV and online clearance monitoring), intradialytic tolerance (blood pressure, cramps, hypotension, symptoms), sodium-related safety (natremia, interdialytic weight gain), and the effects of acidosis correction on nutritional and bone-mineral metabolism, including changes in serum albumin, calcium, phosphorus, and parathyroid hormone (PTH). Feasibility indicators such as recruitment, retention, adherence to treatment and dialysate adjustment, and data completeness will also be described to inform the design of a larger definitive trial.",[95,96,97],"End-stage Renal Disease (ESRD)","Chronic Hemodialysis","Metabolic Acidosis",[99,100,97,101,102,103,104],"Hemodialysis","End-Stage Renal Disease","Oral sodium Bicarbonate","Dialysate Bicarbonate","Pilot Trial","Bicarbonate Supplementation","NOT_YET_RECRUITING","2026-07-18",{"date":108,"type":109},"2026-07-21","ACTUAL",{"date":111,"type":89},"2026-07",{"date":113,"type":89},"2026-09",{"name":5,"class":6},1]