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Can adding urea to dialysis prevent dangerous brain swelling?

NCT ID NCT06366230

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding urea to the dialysis fluid can prevent dialysis disequilibrium syndrome — a set of neurological symptoms like headache, confusion, and seizures — in people with kidney failure who need urgent dialysis for severe electrolyte problems. Researchers will enroll 20 adults with very high blood urea levels who also have dangerous potassium or acid imbalances. The goal is to see if this simple addition allows safe, aggressive dialysis without causing brain-related side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
urea (added to dialysis fluid)
What this could lead to
If it works, this could make aggressive dialysis safer for patients with very high blood urea, reducing the risk of confusion, seizures, or coma during treatment.
What could go wrong
This is a very small, early-phase trial with only 20 participants. The approach is experimental and may not prevent disequilibrium or could cause other complications.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

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

Started

Sep 2025

Expected to finish

Jun 2028

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: * Serum Urea \> 120 * Serum Potassium \> 5.5 or serum CO2 \< 15 or need for aggressive dialysis due to toxic ingestion * need for dialysis Exclusion Criteria: * Pediatric * need for CRRT

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Conditions

The condition(s) this trial relates to.

Acidosis cerebellar ataxia, intellectual disability, and dysequilibrium chronic kidney disease end stage renal failure Hyperkalemia metabolic acidosis dialysis disequilibrium syndrome prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysequilibrium syndrome ESRD Hyperkalemia Metabolic acidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    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

  • Zuckerberg San Francisco General Hospital

    RECRUITING

    San Francisco, California, 94110, United States

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