Health TrialsbyHealthPanel

Adding Urea to the Final Dialysis Fluid

ConditionsDysequilibrium SyndromeESRDHyperkalemiaMetabolic Acidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Serum Urea > 120

Serum Potassium > 5.5 or serum CO2 < 15 or need for aggressive dialysis due to toxic ingestion

need for dialysis

Disqualifiers

Pediatric

need for CRRT

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Urea dialysateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
within 24 hours after starting dialysis
2

Serum potassium concentration

Improvement in serum potassium concentration in mEq/L would be measured and documented with the study

Time frame
Potassium levels every 6 hours for 24 hours after end of dialysis
3

Serum CO2 concentration

Improvement in metabolic acidosis would be monitored by checking serum CO2 concentration in mEq/L

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

Secondary outcomes

1

Serum BUN concentration

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

Time frame
Serum BUN concentration twice a day for 3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov
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