Clinical trial

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

Name

24-41450

Description

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.

Trial arms

Trial start

2024-07-01

Estimated PCD

2028-06-30

Trial end

2028-06-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

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.

Arms:

Urea dialysate

Other names:

Ure-Na

Size

Primary endpoint

Disequilibrium

within 24 hours after starting dialysis

Serum potassium concentration

Potassium levels every 6 hours for 24 hours after end of dialysis

Serum CO2 concentration

Serum CO2 levels every 6 hours for 24 hours after end of dialysis

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-04-15

1 organization

1 product

4 indications

Organization

University of California, San Francisco

Product

Urea

Indication

Cerebellar Ataxia, Areflexia, Pes Cavus, Optic Atrophy, and Sensorineural Hearing Loss

Indication

End-Stage Renal Disease

Indication

Hyperkalemia

Indication

Metabolic Acidosis