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Adding Urea to Dialysis Fluid for Kidney Failure

This study is testing a new approach for patients with advanced kidney failure (ESRD) who have very high levels of urea (BUN), potassium (hyperkalemia), or acid (metabolic acidosis) in their blood. Sometimes, quickly lowering these levels during dialysis can cause problems like disequilibrium syndrome (a condition where rapid changes in body fluids can cause symptoms like headache or nausea). This study will add urea (Ure-Na 15 grams) to the dialysis fluid. The amount added will depend on your blood urea levels. The goal is to prevent a rapid drop in urea while still aggressively treating high potassium or acidosis. The study will measure disequilibrium, potassium levels, and CO2 levels after dialysis. You may be eligible if you are an adult with a serum urea level over 120, high potassium or low CO2, and need dialysis.

Study design
This is an interventional study with a planned enrollment of 20 participants. The phase of the study is not specified.
What's involved
Your labs, vital signs, and symptoms would be closely monitored throughout the dialysis treatment. Blood tests for potassium and CO2 would be taken every 6 hours for 24 hours after dialysis.
Compensation
Not stated in the trial record.
Follow-up
Your potassium and CO2 levels will be monitored for 24 hours after the end of dialysis.

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NCT06366230

Adding Urea to the Final Dialysis Fluid

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, San Francisco
~20 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Urea in the dialysate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disequilibrium
Measured over within 24 hours after starting dialysis
+2 more outcomes measured

Conditions

Dysequilibrium Syndrome
ESRD
Hyperkalemia
Metabolic Acidosis

Explore related trials

Chronic Renal FailureHyperkalemiaMetabolic Acidosis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ramin Sam, MD · PRINCIPAL_INVESTIGATOR · Zuckerberg San Francisco General- UCSF

Who to contact

Ramin Sam, MD
[email protected]
6282066605
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Serum Urea \> 120
Serum Potassium \> 5.5 or serum CO2 \< 15 or need for aggressive dialysis due to toxic ingestion
need for dialysis

Exclusion

Pediatric
need for CRRT

What this trial measures

  • Disequilibriumwithin 24 hours after starting dialysis

    Dialysis disequilibrium syndrome (DDS) refers to an array of neurological manifestations that are seen during or following dialysis. The symptoms can range from headache, nausea, blurred vision, restlessness and confusion to coma and seizures in rare cases. The physician will assess DDS.

  • Serum potassium concentrationPotassium levels every 6 hours for 24 hours after end of dialysis

    Improvement in serum potassium concentration in mEq/L would be measured and documented with the study

  • Serum CO2 concentrationSerum CO2 levels every 6 hours for 24 hours after end of dialysis

    Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L