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NCT Number: NCT06366230

Adding Urea to the Final Dialysis Fluid

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.

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Key information

Conditions

Dysequilibrium Syndrome Acid-Base Imbalance Acidosis Chronic Disease Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperkalemia Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Acidosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location status: Recruiting

Location contact

Ramin Sam, MD

CONTACT

[email protected]

628-206-6605

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urea in the dialysate

Drug

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

Primary outcomes

  1. Disequilibrium

    Time frame: 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.

  2. Serum potassium concentration

    Time frame: 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

  3. Serum CO2 concentration

    Time frame: 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 outcomes

  1. Serum BUN concentration

    Time frame: Serum BUN concentration twice a day for 3 days

    The trend in serum BUN concentration in mg/dL would be followed

Study contacts

Contact information is provided by the study sponsor or research team.

Ramin Sam, MD

CONTACT

[email protected]

6282066605

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: Urea dialysate

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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