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Scientists test how dialysis patients regulate sodium when given water or salt

NCT ID NCT06408077

Knowledge-focused Sponsor: University of Cologne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how the body controls sodium levels in people with end-stage kidney disease who are on dialysis. Researchers will give participants either water or a concentrated salt solution to see how their sodium levels change. The goal is to better understand hyponatremia, a common and dangerous electrolyte disorder, and improve treatment for these patients.

What this could mean

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

Active substance
Water and sodium chloride (salt) solution
What this could lead to
If successful, this could improve how doctors predict and manage sodium imbalances in kidney patients, potentially reducing complications like brain swelling.
What could go wrong
This is a small, early-stage study with only 60 participants, so results may not apply to all patients. The interventions carry risks like fluid overload or rapid sodium 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 60 people

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

Started

Jul 2023

Expected to finish

May 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: * Adult patients ≥18 years * Requirement of renal replacement therapy due to surgical (i.e., nephrectomy) or non-surgical (chronic kidney disease) reason * Stable hemodialysis treatment for at least 3 months * Urine output \<100ml in 24 hours * Glucose-corrected plasma sodium between 135 mmol/l and 145 mmol/l * Plasma potassium between 3.5 mmol/l and 5 mmol/l * Written informed consent Exclusion Criteria: * Peritoneal dialysis patients * Signs of volume expansion or contraction * Congestive heart failure (NYHA ≥2) * acute illness (infection, congestive heart failure, liver cirrhosis, etc.) requiring hospital admission * Uncontrolled arterial hypertension * Hemoglobin ≤8g/dL * Alcohol abuse * Malnutrition * Persons, who are in a dependency/employment relationship with the investigators * Accommodation in an institution by judicial or administrative order

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Conditions

The condition(s) this trial relates to.

end stage renal failure Hyponatremia Water-Electrolyte Imbalance

As listed by the trial registrant

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

Hyponatremia

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

  • Department II of Internal Medicine,University of Cologne

    RECRUITING

    Cologne, 50937, Germany

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