Adding Urea to the Final Dialysis Fluid
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urea in the dialysate.
- Who it may be relevant to
- Registry conditions: Dysequilibrium Syndrome, ESRD, Hyperkalemia, Metabolic Acidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities
Overview
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.
Detailed description
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.
Interventions
- 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.
Primary outcome measures
- Disequilibrium [Time frame: within 24 hours after starting dialysis]
- Serum potassium concentration [Time frame: Potassium levels every 6 hours for 24 hours after end of dialysis]
- Serum CO2 concentration [Time frame: Serum CO2 levels every 6 hours for 24 hours after end of dialysis]
Secondary outcome measures (1)
- Serum BUN concentration [Time frame: Serum BUN concentration twice a day for 3 days]
Eligibility criteria
Inclusion criteria
- Serum Urea > 120
- Serum Potassium > 5.5 or serum CO2 < 15 or need for aggressive dialysis due to toxic ingestion
- need for dialysis
Exclusion criteria
- Pediatric
- need for CRRT
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Zuckerberg San Francisco General Hospital — San Francisco
Identifiers
NCT: NCT06366230 · 24-41450