Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patien… (NCT07688434) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Trial of Oral Sodium Bicarbonate Versus Higher Dialysate Bicarbonate in Hemodialysis Patients With Metabolic Acidosis
Tunisia37 participantsStarted 2026-07
Plain-language 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, 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.
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 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/V 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years.
* Chronic hemodialysis for at least 3 months.
* Stable hemodialysis prescription: 3 times a week, high-flux dialyzers, no major change in dialysis prescription in the previous weeks.
* Predialysis low "alkaline reserves" (serum bicarbonate concentration) according to the operational threshold used in the unit (e.g., "alkaline reserves" \< 22 mmol/L), consistent with KDIGO 2017 definition of metabolic acidosis.
* Ability to give written informed consent.
For the observational group:
* Age ≥ 18 years.
* Chronic hemodialysis for at least 3 months.
* Hemodialysis 3 times a week, high-flux dialyzers.
* Predialysis "alkaline reserves" considered stable and within the locally defined normal range (≥ 22mmol/L).
* Ability to give written informed consent.
Exclusion Criteria:
* Recent hemodynamic instability (e.g., repeated intradialytic hypotension or unstable blood pressure in the previous weeks).
* Recent hospitalization for an acute condition.
* Acute infection or major intercurrent acute event at the time of screening.
* 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).
* Severe digestive disorders limiting oral intake (e.g., persistent vomiting, severe malabsorption, or any condition preventing safe oral Bicardis administration).
* Known hypernatremia or high risk of uncontrolled sodium and fluid overload (as judged b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares taking oral sodium bicarbonate tablets to adjusting the dialysate bicarbonate concentration — can you explain what that difference means for my day-to-day routine, and which approach might be more manageable given my current treatment schedule?
2The trial is listed as 'not yet recruiting' — how long do you think it might be before enrollment opens, and should I be considering other ways to manage my metabolic acidosis in the meantime?
3Since this is listed as Phase NA and described as a pilot trial, what does that mean about how much is already known about the safety and effectiveness of these two approaches, and how should that affect my decision about whether to participate?
4The study measures changes in predialysis serum bicarbonate over 28 days — is my current bicarbonate level low enough that correcting it is a priority for me right now, and what would happen if it stays undertreated?
5Are there existing standard-of-care options — like adjusting my current dialysate settings or starting oral bicarbonate outside of a trial — that you'd recommend I try first before waiting for this study to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Predialysis Serum Bicarbonate ("Reserves Alcalines") Between Day 0 and Day 42