Adding Urea to the Final Dialysis Fluid

NCT ID: NCT06366230

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-06-30

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.

Conditions

Dysequilibrium Syndrome; ESRD; Hyperkalemia; Metabolic Acidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Urea dialysate

Patients who had urea added to the final dialysis fluid

Group Type: EXPERIMENTAL

Urea in the dialysate

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ure-Na

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramin Sam, MD

Role: PRINCIPAL_INVESTIGATOR

Zuckerberg San Francisco General- UCSF

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Countries

United States

Central Contacts

Ramin Sam, MD

Role: CONTACT

ramin.sam@ucsf.edu

6282066605

Facility Contacts

Ramin Sam, MD

Role: primary

ramin.sam@ucsf.edu

628-206-6605

Other Identifiers

24-41450

Identifier Type: -

Identifier Source: org_study_id