Pill vs. machine: which fixes acid imbalance better for dialysis patients?
NCT ID NCT07688434
First seen Jul 07, 2026 · Last updated Jul 22, 2026 · Updated 7 times
Summary
This study tests two common methods to treat metabolic acidosis—a condition where blood becomes too acidic—in people on long-term hemodialysis for kidney failure. One group takes oral sodium bicarbonate capsules, while the other gets a higher bicarbonate concentration in their dialysis fluid. Over four weeks, researchers measure changes in blood bicarbonate levels to see which approach works better and is safer. The results will help design a larger, more definitive trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sodium bicarbonate
- What this could lead to
- If one method works better, it could improve acid balance and reduce complications in dialysis patients.
- What could go wrong
- This is a small pilot study with only 37 participants, so results may not apply broadly. Both treatments may cause side effects like high sodium or blood pressure changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 by the investigator). * Severe uncontrolled hypercalcemia or hypocalcemia. * 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). * Refusal to participate or inability to provide written informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Social security fund polyclinic
Sfax, 3080, Tunisia
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