1. Serum Aluminium monitoring in 16,530 dialysis patients in England and Wales: compliance with national guidelines? Udaya P Udayaraj 1, E J Lamb 2, R.Steenkamp 1, F. Caskey 1, S.J. Davies 3, D. Ansell 1. 1 UK Renal Registry ; 2 Clinical Biochemistry, Kent and Canterbury hospital; 3 University Hospitals North Staffordshire, Stoke-on-Trent, UK

2. Introduction (1) Reverse osmosis/ deionisation has eliminated Aluminium (AL) from dialysate water AL containing binders have become the predominant source of AL to dialysis patients The use of AL containing binders has declined over the years But guidelines continue to recommend routine serum AL monitoring

3. Introduction (2) The UK guidelines (2002): Dialysate water AL BS ISO 13959 2001 requirements ( monthly) Serum AL 3 monthly in all HD patients 3 monthly in PD patients on AL containing binders. No patient whose ferritin is > 100  g/L should have a serum AL > 2.2  mol/L

4. Introduction (3) Cost of serum AL test ( £11.25 per test) For a HD unit ~ 400 patients 3 monthly serum AL testing costs £ 18,000 /year KDOQI Guidelines (2003): Serum AL yearly in all dialysis patients 3 monthly for those on AL containing binders.

5. Objectives To investigate Compliance with guidelines on serum AL monitoring in England and Wales Frequency of patients with high AL levels and trend over the years 2000-2004 If high AL levels were associated with use of AL containing binders

6. Methods (1) Prevalent dialysis patients (2000-2004) on the UKRR database % of patients in each unit who had AL measured during the year % of patients with high AL levels (> 2.2  mol/L) Renal units with no Al data were contacted to identify AL monitoring policies

7. Methods (2) UKRR did not collect data on use of phosphate binders or dialysate AL IT drug prescription records of patients with high AL levels ( 2000-2004) at Bristol were examined for use of AL containing binders Chi-squared test was used to compare groups

8. Compliance with guidelines on serum Al monitoring - 2004 RA guidelines – Only 4.5 % HD patients complied KDOQI guidelines - 39% of HD patients & 15% of PD patients complied Of the 49 centres reporting to UKRR in 2004 Survey of 15 HD centres with no AL data 9 centres confirmed do not measure AL routinely. The policy unknown in remaining 6 centres. No. of centres with no AL data No. of centres with data on < 10% patients/year HD157 PD249

9. Trends in % patients with high AL levels 2000-2004 * Chi squared p value <0.0001 between years 2000 and 2004 * *

10. Causes of high AL levels in a single centre 36 patients (2.2%) had high AL levels 2000-2004 33 of them were on AL containing binders. AL levels normalised in all after withdrawal of AL containing binders 2 patients had sporadic high levels which normalised without intervention. One patient died of unrelated cause without further levels done

11. Discussion Compliance with guidelines on serum AL monitoring is low and has declined over the years The proportion of patients with high AL levels is low and has declined over the years - ? related to the introduction of newer non AL containing binders The utility of a screening tool depends on the prevalence of the condition for which it is used. In a single centre, 92 % of the high AL levels were due to exposure to AL containing binders

12. Conclusions There is considerable non compliance with the guidelines. Many centres have stopped routine testing for serum AL Given the cost (£ 11.25) and the declining frequency of high AL levels, guidelines for routine testing of serum AL in all dialysis patients needs review. It may however be useful in patients with suspected AL toxicity ; those on AL containing binders; ? Home HD patients

13. UK guidelines (2007) Serum AL should be measured every 3 months in all patients receiving oral aluminium hydroxide No patient whose ferritin is > 100  g/L should have a serum AL > 2.2  mol/L Dialysate water AL should be checked 3 monthly