Pill vs. machine: which fixes acid imbalance better for dialysis patients?

NCT ID NCT07688434

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Social security fund polyclinic

    Sfax, 3080, Tunisia

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