Urea in Dialysis Fluid for Renal Disease

Overseen By Ramin Sam, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, San Francisco

Disqualifiers: Pediatric, need for CRRT

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Urea in Dialysis Fluid for Renal Disease?

The research indicates that urea kinetic modeling can improve dialysis efficiency and patient nutritional status, suggesting that managing urea levels is important for effective dialysis treatment. This implies that using urea in dialysis fluid might help optimize dialysis outcomes by better controlling urea removal. ^{1 2 3 4 5}

Is urea in dialysis fluid safe for humans?

The research does not provide specific safety data on using urea in dialysis fluid, but it discusses how urea behaves in the body during dialysis, which is important for understanding treatment effects. ^{6 7 8 9 10}

How does the treatment using urea in dialysis fluid differ from other treatments for renal disease?

Using urea in dialysis fluid is unique because it focuses on the kinetics of urea, a small molecule, to assess dialysis adequacy and nutritional status, which differs from traditional methods that rely on blood urea and creatinine levels. This approach may offer a more precise understanding of how well dialysis is working, especially in continuous therapies like peritoneal dialysis compared to intermittent ones like hemodialysis. ^{8 9 11 12 13}

Research Team

Ramin Sam, MD

Principal Investigator

Zuckerberg San Francisco General- UCSF

Eligibility Criteria

This trial is for patients with advanced kidney failure who have dangerously high levels of potassium or severe acidosis, and very high blood urea nitrogen (BUN) levels. It's not suitable for those who might experience a rapid drop in BUN leading to disequilibrium syndrome.

Inclusion Criteria

I require dialysis.

Serum Urea > 120

My blood potassium is high, or my CO2 levels are low, or I need dialysis due to poisoning.

Exclusion Criteria

I am under 18 years old.

I require continuous renal replacement therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive dialysis with urea added to the final dialysis fluid to prevent disequilibrium syndrome

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

Monitoring every 6 hours for 24 hours, then twice a day for 3 days

Treatment Details

Interventions

• Urea

Trial Overview The study tests adding urea to the dialysis fluid. This could help manage serum BUN levels while aggressively treating high potassium or acidosis without risking disequilibrium syndrome during dialysis.

Participant Groups

Group I: Urea dialysate Experimental Treatment 1 Intervention

Patients who had urea added to the final dialysis fluid

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of ultrafiltration on peripheral urea sequestration in haemodialysis patients. [2019]

2. Poland pubmed.ncbi.nlm.nih.gov

[Use of urea kinetic modeling in patients on maintenance hemodialysis]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Urea modeling and Kt/V: a critical appraisal. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of high-flux hemodiafiltration efficiency using an on-line urea monitor. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Urea kinetics during hemodialysis measured by microdialysis--a novel technique. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Direct dialysis quantification: investigation of the impact of dialysate preservation techniques on solute assays. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

A simplified approach to understanding urea kinetics in peritoneal dialysis. [2013]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A simplified approach to understanding urea kinetics in peritoneal dialysis and hemodialysis. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Causes, kinetics and clinical implications of post-hemodialysis urea rebound. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Urea kinetics and when to commence dialysis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Urea metabolism in chronic renal failure. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Nitrogen and urea metabolism during continuous ambulatory peritoneal dialysis. [2019]