RecruitingPhase 1Phase 2NCT06366230

Adding Urea to the Final Dialysis Fluid

Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities

Sponsor

University of California, San Francisco

Enrollment

20 participants

Start Date

Sep 16, 2025

Study Type

INTERVENTIONAL

Conditions

Hyperkalemia Metabolic Acidosis Dysequilibrium Syndrome ESRD

Summary

At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding urea (a waste product normally removed by dialysis) back into the dialysis fluid can reduce the harmful effects of removing it too quickly, particularly in critically ill patients who need urgent dialysis. **You may be eligible if...** - Your blood urea level is very high (above 120) - Your potassium is dangerously high, your bicarbonate (CO2) is very low, or you need dialysis urgently due to a toxic ingestion - You require dialysis treatment **You may NOT be eligible if...** - You are a child (pediatric patient) - You need continuous renal replacement therapy (CRRT), a specialized form of dialysis for critically ill patients Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUrea in the dialysate

Adding urea to the dialysis fluid. Ure-Na 15 grams would be used. It would be added to the acid component of the dialysis fluid. The amount added would depend on the serum BUN concentration and is determined by a simple calculation. It would be available in powder form. Urea would be added just to the first 1-3 dialysis treatments as needed.