Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
ID06366230

Adding Urea to the Final Dialysis Fluid to Prevent Dialysis Disequilibrium in Patients Needing Aggressive Dialysis for Electrolyte Abnormalities

Led by University of California, San Francisco · Updated on 2026-02-12

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with advanced kidney failure often face serious issues like high potassium levels, severe acidosis, and very high blood urea nitrogen (BUN) levels. These patients require aggressive dialysis to manage these problems, but rapid lowering of BUN can cause a dangerous condition called disequilibrium syndrome. This research explores adding urea to the dialysis fluid to prevent this rapid BUN decrease while still addressing potassium and acidosis concerns. The study uses Ure-Na 15 gram tablets to add urea to the dialysis fluid. The amount of urea added is carefully calculated based on the dialysis system and the patient's serum urea levels to keep the dialysate urea concentration slightly lower than the patient's serum level. This intervention is applied during the first one to three dialysis treatments as needed, and patients who receive this urea-added dialysate are closely monitored. Participants will have their laboratory values, vital signs, and symptoms checked frequently during and after dialysis. Key outcomes measured include the occurrence of disequilibrium syndrome within 24 hours after dialysis, serum potassium and CO2 levels every six hours for 24 hours post-dialysis, and serum BUN levels twice daily for three days. This monitoring ensures the safety and effectiveness of the urea addition approach throughout the study duration.

CONDITIONS

Brief Title

Adding Urea to the Final Dialysis Fluid

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Serum urea nitrogen (BUN) greater than 120
  • Serum potassium greater than 5.5 or serum CO2 less than 15 or need for aggressive dialysis due to toxic ingestion
  • Need for dialysis treatment
Not Eligible

You will not qualify if you...

  • Pediatric patients (under 18 years old)
  • Need for continuous renal replacement therapy (CRRT)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 dialysis treatments as needed

Participants receive dialysis with urea added to the dialysis fluid during the first 1 to 3 dialysis treatments as needed. Labs, vital signs, and symptoms are closely monitored throughout the dialysis sessions.

Frequent monitoring during dialysis treatments and serum potassium and CO2 levels every 6 hours for 24 hours after dialysis

Trial Site Locations

Total: 1 location

1

Zuckerberg San Francisco General Hospital

San Francisco, California, United States, 94110

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Research Team

R

Ramin Sam, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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