Preliminary safety study of the Automated Wearable Artificial Kidney (AWAK) in Peritoneal Dialysis patients.

BACKGROUND: Regeneration of peritoneal dialysis (PD) fluid using sorbent technology can provide flexibility and improve quality of life. This study examined the safety and efficacy of the automated wearable artificial kidney (AWAK) device in PD patients. METHODS: This pilot study included prevalent PD patients from a single center in Singapore between 2016 and 2018. Participants underwent up to nine AWAK therapies over 72 h and were followed up for 1 month. Primary outcomes were serious adverse events (SAEs) and completion of nine therapies without device deficiency. Secondary outcomes were weekly peritoneal Kt/Vurea, solutes clearance and adverse events (AEs). RESULTS: Twenty-one patients were screened and 15 were included in the study. Device alterations were required to overcome issues including flow occlusions initially, which resulted in three cohorts (n = 2, 2 and 11 respectively). No SAEs were observed during the study and at the follow-ups. Common AEs were abdominal pain/discomfort (60%) and bloatedness (47%). The median estimated peritoneal weekly Kt/Vurea was 3.0 (interquartile range: 2.2-4.8). There were significant reductions in pre- and post-study median serum urea (20.8 vs. 14.9 mmol/L; p = 0.001), creatinine (976.0 vs. 667.5 µmol/L; p = 0.001), phosphate (1.7 vs. 1.5 mmol/L; p = 0.03), and ß2-microglobulin (29114.0 vs. 26339.0 µg/L; p = 0.048). Fluid reabsorption occurred among patients with residual kidney function. However, median body weights were not significantly different pre- and post-study (66.4 vs. 65.7 kg; p = 0.83). CONCLUSIONS: This preliminary study demonstrated that no SAEs were observed with the AWAK-PD device; however, 60% of participants developed abdominal pain/discomfort. Further device enhancements are needed to improve ultrafiltration and reduce AEs.

Could metformin be used in patients with diabetes and advanced chronic kidney disease?

Diabetes is an important cause of end stage renal failure worldwide. As renal impairment progresses, managing hyperglycaemia can prove increasingly challenging, as many medications are contra-indicated in moderate to severe renal impairment. Whilst evidence for tight glycaemic control reducing progression to renal failure in patients with established renal disease is limited, poor glycaemic control is not desirable, and is likely to lead to progressive complications. Metformin is a first-line therapy in patients with Type 2 diabetes, as it appears to be effective in reducing diabetes related end points and mortality in overweight patients. Cessation of metformin in patients with progressive renal disease may not only lead to deterioration in glucose control, but also to loss of protection from cardiovascular disease in a cohort of patients at particularly high risk. We advocate the need for further study to determine the role of metformin in patients with severe renal disease (chronic kidney disease stage 4-5), as well as patients on dialysis, or pre-/peri-renal transplantation. We explore possible roles of metformin in these circumstances, and suggest potential key areas for further study.

Practical aspects of volume control in chronic kidney disease using whole body bioimpedance.

BACKGROUND: Fluid status is an independent predictor of mortality in dialysis patients. Current methods of fluid assessment have several limitations. SUMMARY: An ideal method should be cheap, portable, easy to perform without extensive training, reproducible and determines patients' excess or deficit of total body water. Bioimpedance analysis (BIA) fulfils many of these criteria and can give additional information on fat and lean tissue composition. The accuracy and precision of BIA has been shown to be equivalent to the 'gold standard' direct estimation techniques. KEY MESSAGES: Although there remains some concern about its validity in dialysis patients, fluid overload determined by BIA has been shown to predict mortality. BIA-guided fluid management appears superior to conventional fluid management in achieving clinically important outcomes such as reduction in blood pressure, left ventricular mass index, and arterial stiffness. Accurate setting of dry weight might also help preserve residual renal function by limiting episodes of dehydration. Nevertheless, as with all new technologies, there are issues that still need to be resolved. This will be achieved only with larger prospective interventional studies to explore its specific roles in dialysis cohorts.