Adding Urea to the Final Dialysis Fluid

University of California San Francisco (UCSF)

Status and phase: Begins enrollment in 6 months; Phase 2; Phase 1

Conditions: Hyperkalemia; ESRD; Dysequilibrium Syndrome; Metabolic Acidosis

Treatments: Drug: Urea in the dialysate

Study type: Interventional

Funder types: Other

Identifiers

NCT06366230

24-41450

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Urea dialysate

Experimental group

Description:

Patients who had urea added to the final dialysis fluid

Treatment:

Drug: Urea in the dialysate