University of California, San Francisco
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.
Dysequilibrium Syndrome
ESRD
Hyperkalemia
Metabolic Acidosis
Urea in the dialysate
PHASE1
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 20 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities |
| Actual Study Start Date : | 2025-07-01 |
| Estimated Primary Completion Date : | 2028-06-30 |
| Estimated Study Completion Date : | 2028-06-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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Not yet recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110