Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Actively Recruiting
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