Adding Urea to the Final Dialysis Fluid

Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06366230

Acronym

Urea dialysate

Enrollment

Registered

2024-04-15

Start date

2025-09-16

Completion date

2028-06-30

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysequilibrium Syndrome, ESRD, Hyperkalemia, Metabolic Acidosis

Keywords

ESRD, Urea, Disequilibrium, Potassium, Acid/base

Brief summary

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

DRUGUrea 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Disequilibrium	within 24 hours after starting dialysis	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.
Serum potassium concentration	Potassium levels every 6 hours for 24 hours after end of dialysis	Improvement in serum potassium concentration in mEq/L would be measured and documented with the study
Serum CO2 concentration	Serum CO2 levels every 6 hours for 24 hours after end of dialysis	Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L

Secondary

Measure	Time frame	Description
Serum BUN concentration	Serum BUN concentration twice a day for 3 days	The trend in serum BUN concentration in mg/dL would be followed

Countries

United States

Contacts

CONTACTRamin Sam, MD

ramin.sam@ucsf.edu6282066605

PRINCIPAL_INVESTIGATORRamin Sam, MD

Zuckerberg San Francisco General- UCSF

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026