Adding Urea to the Final Dialysis Fluid (Urea dialysate)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ESRD; Dysequilibrium Syndrome; Hyperkalemia; Metabolic Acidosis
• Intervention / Treatment: Drug: Urea in the dialysate

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ramin Sam, MD; Phone Number: 6282066605; Email: ramin.sam@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Zuckerberg San Francisco General Hospital
      • Contact: Ramin Sam, MD; Phone Number: 628-206-6605; Email: ramin.sam@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urea dialysate; Patients who had urea added to the final dialysis fluid	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.; Other Names: Ure-Na

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum BUN concentration	The trend in serum BUN concentration in mg/dL would be followed	Serum BUN concentration twice a day for 3 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Ramin Sam, MD, Zuckerberg San Francisco General- UCSF

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: ESRD; Potassium; Urea; Disequilibrium; Acid/base
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Renal Insufficiency; Water-Electrolyte Imbalance; Renal Insufficiency, Chronic; Acid-Base Imbalance; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Kidney Failure, Chronic; Acidosis; Hyperkalemia; Dysequilibrium syndrome; Organic Chemicals; Amides; Urea
• Other Study ID Numbers: 24-41450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes