KDIGO Clinical Practice Guideline for Acute Kidney Injury
Dialysis fluids and replacement fluids in patients with AKI: Recommendations and Rationale

• 5.7.4: We recommend that dialysis fluids and replacement fluids in patients with AKI, at a minimum, comply with American Association of Medical Instrumentation (AAMI) standards regarding contamination with bacteria and endotoxins. (1B)

Rationale

Replacement fluids for HF or HDF are infused directly into the patient’s circulation and should be sterile. A potential major step forward in acute RRT, reducing the costs and the need for storage of fluids, is the on-line production of replacement fluids, which is achieved by passing water and/or dialysate through two or three ultrafilters before being infused.^757,758 On-line production of replacement fluids has not yet been approved by the FDA or by some regulatory authorities in Europe.

Conventional IHD uses nonsterile dialysate, as there is no direct contact between blood and dialysate. However, with the use of high-permeability membranes, the lower blood side pressures at the end of the dialyzer filter may allow backfiltration of dialysate to the blood,⁷⁵⁹ raising the possibility of endotoxin or other contaminant exposure. Two studies confirmed microbial contamination of (locally prepared and commercial) fluids and circuitry during CRRT.^760,761 Dialysate for CRRT should preferably be ultrapure, and should at least comply with quality standards for dialysis water and dialysis fluids that may differ worldwide (Table 23).⁷⁶²

Finally, an international quality standard for dialysis fluid is in preparation by the International Society for Standardization. Until international standards are in place, we recommend that dialysis fluids and replacement fluids in patients with AKI, at a minimum, comply with AAMI standards for bacteria and endotoxins. When local standards exceed AAMI standards, local standards should be followed (Table 23).