Adding Urea to the Final Dialysis Fluid

Phase 1

Not yet recruiting

• Conditions: Hyperkalemia; Dysequilibrium Syndrome; ESRD; Metabolic Acidosis
• Interventions: Drug: Urea in the dialysate

• Registration Number: NCT06366230
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-10
• Last Update Submitted: 2024-04-10
• Study First Posted: 2024-04-15
• Last Update Posted: 2024-04-15
• Study Start: 2024-07-01
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Urea dialysate	Urea in the dialysate	Patients who had urea added to the final dialysis fluid

Primary Outcome Measures

Name	Time	Method
Disequilibrium	within 24 hours after starting dialysis	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.
Serum potassium concentration	Potassium levels every 6 hours for 24 hours after end of dialysis	Improvement in serum potassium concentration in mEq/L would be measured and documented with the study
Serum CO2 concentration	Serum CO2 levels every 6 hours for 24 hours after end of dialysis	Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L

Secondary Outcome Measures

Name	Time	Method
Serum BUN concentration	Serum BUN concentration twice a day for 3 days	The trend in serum BUN concentration in mg/dL would be followed

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States