Recruiting
Phase 1
Phase 2

Dialysis with Urea

Sponsor:

UCLA

Code:

NCT06366230

Conditions

Dysequilibrium Syndrome

ESRD

Hyperkalemia

Metabolic Acidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Urea in the dialysate

Study Details

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.

Conditions

Dysequilibrium Syndrome

ESRD

Hyperkalemia

Metabolic Acidosis

Study ID

NCT06366230

Start date

Sep 16, 2025

Status verified date

Feb, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Urea dialysate

Patients who had urea added to the final dialysis fluid

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ramin Sam, MD

6282066605ramin.sam@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Ramin Sam, MD

628-206-6605ramin.sam@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • ESRD
  • Urea
  • Disequilibrium
  • Potassium
  • Acid/base

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-02-12.