Adding Urea to the Final Dialysis Fluid

ESRD Clinical Trial

Official title:

Adding Urea to the Final Dialysis Fluid in Order to Prevent Dialysis Disequilibrium in Patients Who Need Aggressive Dialysis for Electrolyte Abnormalities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366230
• Other study ID #: 24-41450
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Ramin Sam, MD
• Phone: 6282066605
• Email: ramin.sam[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ure-Na 15 gram tablets would be used to add to the dialysis fluid How much urea to add would be a simple calculation based on the 45X dialysis system and the patients serum urea concentration. The dialysate fluid urea concentration would be made to be about 15-40 mg/dL lower than the serum concentration. The patients labs/vitals and symptoms would be closely monitored throughout the dialysis treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• ESRD
• Hyperkalemia
• Metabolic Acidosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disequilibrium	Dialysis disequilibrium syndrome (DDS) refers to an array of neurological manifestations that are seen during or following dialysis. The symptoms can range from headache, nausea, blurred vision, restlessness and confusion to coma and seizures in rare cases. The physician will assess DDS.	within 24 hours after starting dialysis
Primary	Serum potassium concentration	Improvement in serum potassium concentration in mEq/L would be measured and documented with the study	Potassium levels every 6 hours for 24 hours after end of dialysis
Primary	Serum CO2 concentration	Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L	Serum CO2 levels every 6 hours for 24 hours after end of dialysis
Secondary	Serum BUN concentration	The trend in serum BUN concentration in mg/dL would be followed	Serum BUN concentration twice a day for 3 days