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
This test tries adding urea to the dialysis fluid for adults with advanced kidney failure who have very high blood urea and need rapid lowering of potassium or correction of severe acidosis.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06366230 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional approach adds measured amounts of urea (using Ure-Na 15 g tablets) to the dialysate during hemodialysis so the dialysate urea concentration is kept about 15–40 mg/dL lower than the patient’s serum value. The calculation of how much urea to add is based on the dialysis system and the patient’s serum urea concentration. The aim is to allow aggressive removal of potassium and correction of metabolic acidosis while preventing a rapid drop in serum osmolality that can cause disequilibrium syndrome. Patients’ labs, vital signs, and symptoms are closely monitored throughout treatment to guide adjustments and safety assessments.
Who should consider this trial
Good fit: Ideal candidates are adults with end-stage renal disease who need dialysis and have serum urea >120 and either potassium >5.5, serum CO2 <15, or another urgent indication for aggressive dialysis, and who are not pediatric and do not require CRRT.
Not a fit: Pediatric patients, those requiring continuous renal replacement therapy, or patients with lower BUN or stable electrolytes are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this method could allow safe, rapid correction of life-threatening hyperkalemia or severe acidosis in patients with very high BUN while reducing the risk of dialysis disequilibrium.
How similar studies have performed: This specific tactic of adding urea to dialysate is relatively novel with limited published data, mainly theoretical discussion and small case-level reports rather than large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Ramin Sam, MD — Zuckerberg San Francisco General- UCSF
- Study coordinator: Ramin Sam, MD
- Email: ramin.sam@ucsf.edu
- Phone: 6282066605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.