A prospective observational study of iron isomaltoside in haemodialysis patients with chronic kidney disease treated for iron deficiency (DINO).

BACKGROUND: Iron deficiency is frequent in haemodialysis (HD) patients with chronic kidney disease (CKD), and intravenous iron is an established therapy for these patients. This study assessed treatment routine, effectiveness, and safety of iron isomaltoside (IIM) 5% (Diafer®) in a HD cohort. METHODS: This prospective observational study included 198 HD patients converted from iron sucrose (IS) and treated with IIM according to product label and clinical routine. Data for IIM were compared to historic data for IS in 3-month intervals. The primary endpoint was to show non-inferiority for IIM versus IS in haemoglobin (Hb) maintenance. RESULTS: Most patients (> 60%) followed a fixed low-dose iron treatment protocol. Three minutes were required for preparation and administration of IIM. Erythropoiesis-stimulating agent (ESA) was used in > 80% of patients during both IIM and IS phases. The maintenance of Hb was similar with both iron drugs; the mean Hb level was 11 g/dL, and the mean change of 0.3 g/dL (95% confidence interval: 0.1, 0.5) for IIM 0-3 months compared to IS demonstrated non-inferiority. Nine adverse drug reactions were reported in 2% of patients administered IIM. All patients had uneventful recoveries. The frequency of metallic taste was higher with IS compared to IIM (34% versus 0.5%, p < 0.0001). CONCLUSIONS: IIM is effective and well tolerated by CKD patients on HD. IIM was non-inferior to IS in maintenance of Hb, and had similar ESA requirements. The fast-push injection of IIM may enable logistical benefits in clinical practice, and the low frequency of metallic taste contributes to patient convenience. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02301026, study registered November 25, 2014.

Knowing what we do and doing what we should: quality assurance in hemodialysis.

An international group of around 50 nephrologists and scientists, including representatives from large dialysis provider organisations, formulated recommendations on how to develop and implement quality assurance measures to improve individual hemodialysis patient care, population health and cost effectiveness. Discussed were methods thought to be of highest priority, those clinical indicators which might be most related to meaningful patient outcomes, tools to control treatment delivery and the role of facilitating computerized expert systems. Emphasis was given to the use of new technologies such as measurement of online dialysance and ways of assessing fluid status. The current evidence linking achievement of quality criteria with patient outcomes was reviewed. This paper summarizes useful processes and quality measures supporting quality assurance that have been agreed across the expert panel. It also notes areas where more understanding is required.

Monitor turnaround time and time efficiency in hemodialysis delivery--a global comparison.

BACKGROUND/AIMS: Increasing cost pressure has forced shortening of dialysis treatments. The aim of this study was to benchmark the hemodialysis (HD) delivery monitor turnaround time and time efficiency in a global comparison. METHODS: 683 HD deliveries in 26 Gambro Healthcare clinics in Europe, Taiwan and the USA were assessed using the Treatment Mapping methodology. RESULTS: Consolidated mean monitor turnaround time was 324.4 min. On average, 69% consisted of the HD treatment and 31% (102.8 min) of other activities: monitor preparation, monitor disinfection and monitor waiting--roughly one third each. USA had the shortest monitor turnaround, dialysis treatment and disinfection times. However, time efficiency--the percentage of monitor turnaround time on dialysis--was the lowest in the USA (68 vs. 69 and 74% in Europe and Taiwan) as monitor preparation, undress and waiting were the longest in USA. CONCLUSION: A monitor/disposable design to minimize time for preparation, undress and disinfection would reduce the cost of operational time without compromising quality.