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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urea dialysate | Experimental | Patients who had urea added to the final dialysis fluid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urea in the dialysate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | Serum CO2 levels every 6 hours for 24 hours after end of dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Serum BUN concentration | The trend in serum BUN concentration in mg/dL would be followed | Serum BUN concentration twice a day for 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramin Sam, MD | Contact | 6282066605 | ramin.sam@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ramin Sam, MD | Zuckerberg San Francisco General- UCSF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | Recruiting | San Francisco | California | 94110 | United States |
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| ID | Term |
|---|---|
| C535731 | Dysequilibrium syndrome |
| D007676 | Kidney Failure, Chronic |
| D006947 | Hyperkalemia |
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D014508 | Urea |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000137 | Acid-Base Imbalance |