Abstract
BackgroundPre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption.MethodsWe conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting.ResultsMicrobial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%.ConclusionModern CCS is bacteriologically safe and its performance statistically equivalent to PPC.
Highlights
Pre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption
Throughout the 8-week study, none of the machines on CCS or PPC arm of the study had alarmed or temporarily ceased functioning as a result of the dialysate conductivity deviating from the preset limit
The automated CCS is equipped with variety of sensors and monitors to alert users about system malfunction or potentially hazardous condition, such as when a process is taking longer than expected to complete, or a critical process is not completed properly, or some parameters have exceeded prespecified limits
Summary
Pre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption. The dialysis fluid or dialysate required for Hemodialysis (HD) is produced continuously during treatment by mixing purified water, an Acid (AC) and a Bicarbonate concentrates (BC). PPC is costly and incurs microbial contamination risk as well as considerable environmental cost and occupational safety risk (see below). Even though this is costlier, the powder form is free from the risk of microbial contamination. It is widely used in Europe but the cartridge is not universally suitable for all types of hemodialysis machines
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