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Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patients With Metabolic Acidosis
Sponsor: University of Sfax
Summary
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, two-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. Approximately 30 acidotic patients (serum bicarbonate \< 22 mmol/L) will be randomized 1:1 to receive either oral sodium bicarbonate or an increase in dialysate bicarbonate for 4 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 28 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/V and online clearance monitoring), intradialytic tolerance (blood pressure, cramps, hypotension, symptoms), and sodium-related safety (natremia, interdialytic weight gain). 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.
Official title: Comparative Pilot Trial of Oral Sodium Bicarbonate Versus Increased Dialysate Bicarbonate in Chronic Hemodialysis Patients With Metabolic Acidosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2026-07
Completion Date
2026-09
Last Updated
2026-07-07
Healthy Volunteers
No
Interventions
Oral sodium bicarbonate
Oral sodium bicarbonate given as Bicardis 500 mg capsules, used as a dietary supplement in Tunisia, administered according to a predefined stepwise dosing algorithm based on weekly predialysis serum (or plasma) bicarbonate concentrations, so-called "reserves alcalines" or "alkaline reserves" in local laboratory reports. At baseline and at each weekly visit, the dose is adapted as follows: 1 capsule/day if serum bicarbonate is 20-21.9 mmol/L, 2 capsules/day if 18-19.9 mmol/L, 3 capsules/day if 16-17.9 mmol/L, and 4 capsules/day if \< 16 mmol/L, with verification of adherence and investigation of intercurrent causes in case of very low values. The daily dose may be divided into 2-3 intakes according to digestive tolerance and the patient's routine. The goal is a progressive correction of metabolic acidosis over 4 weeks without excessive sodium load or intolerance.
Increased Dialysate Bicarbonate
Adjustment of the dialysate bicarbonate concentration according to a predefined stepwise algorithm based on weekly predialysis serum (or plasma) bicarbonate concentrations ("reserves alcalines" / "alkaline reserves" in local laboratory reports): +1 mmol/L if serum bicarbonate is 20-21.9 mmol/L, +2 mmol/L if 18-19.9 mmol/L, +3 mmol/L if 16-17.9 mmol/L, and a larger or individualized increase considered if \< 16 mmol/L, with return to the previous level in case of post-dialysis alkalosis or intolerance. Dialysate sodium concentration is kept constant according to the unit's standard.
Locations (1)
Social security fund polyclinic
Sfax, Tunisia