Background: Additional small-solute clearances during standard thrice-weekly hemodialysis treatments have not improved patient survival. However, these treatments have limited middle-molecule clearances. Thus, newer therapies designed to increase middle-molecule clearances need to be developed and evaluated.
Study design: Pilot clinical trial to measure beta(2)-microglobulin and phosphate clearances with a wearable hemodialysis device.
Setting & participants: 8 regular hemodialysis patients under the care of a university teaching hospital.
Intervention: Patients were fitted with a wearable hemodialysis device for 4 to 8 hours.
Outcomes: All patients tolerated the treatment.
Results: Average amount of beta(2)-microglobulin removed was 99.8 +/- 63.1 mg, with mean clearance of 11.3 +/- 2.3 mL/min, and an average of 445.2 +/- 326 mg of phosphate was removed, with mean plasma phosphate clearance of 21.7 +/- 4.5 mL/min. These clearances compared favorably with mean urea and creatinine plasma clearances (21.8 +/- 1.6 and 20.0 +/- 0.8 mL/min, respectively).
Limitations: Proof-of-concept preliminary trial. Additional studies are warranted to confirm these positive preliminary data.
Conclusions: This wearable artificial kidney potentially provides effective beta(2)-microglobulin and phosphate clearances and, by analogy, middle-molecule clearances.
Trial registration: ClinicalTrials.gov NCT00454974.