A Phase 1/2 interventional study of Urea in the dialysate in Dysequilibrium Syndrome, ESRD and Hyperkalemia, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by University of California, San Francisco · Phase 1/2, Interventional, and Treatment
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.
Ure-Na 15 gram tablets would be used to add to the dialysis fluid How much urea to add would be a simple calculation based on the 45X dialysis system and the patients serum urea concentration. The dialysate fluid urea concentration would be made to be about 15-40 mg/dL lower than the serum concentration. The patients labs/vitals and symptoms would be closely monitored throughout the dialysis treatment.
Exclusion Criteria:
Patients who had urea added to the final dialysis fluid
Drug: Urea 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.
Also known as: Ure-Na
Disequilibrium
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.
Time frame: within 24 hours after starting dialysis
Serum potassium concentration
Improvement in serum potassium concentration in mEq/L would be measured and documented with the study
Time frame: Potassium levels every 6 hours for 24 hours after end of dialysis
Serum CO2 concentration
Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L
Time frame: Serum CO2 levels every 6 hours for 24 hours after end of dialysis
Serum BUN concentration
The trend in serum BUN concentration in mg/dL would be followed
Time frame: Serum BUN concentration twice a day for 3 days
Plan to share: No
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Dysequilibrium syndrome
University of California, San Francisco