title: Effect of acetate-free biofiltration on the anaemia of haemodialysis patients: a prospective cross-over study.
abstract: BACKGROUND
  The discussion about the pathogenesis of renal anaemia, whether it is primarily due to relative erythropoietin (Epo) deficiency or to uraemic inhibition of erythropoiesis, is still open. Although it has so far not been possible to identify or isolate a substance retained in uraemia with a suppressive action directed specifically against red-cell production, dialysis therapy can improve the effect of both residual endogenous Epo and exogenous rHuEpo. To what extent the mode and/or the dose of dialysis influence Epo efficacy is as yet poorly understood.
  
  
  METHODS
  This study was performed as a single-centre trial. The protocol included a run-in period of 4 months followed by a prospective cross-over study including 6 months each of acetate-free biofiltration (AFB) with a high-flux biocompatible membrane and standard bicarbonate dialysis (BD) with a low-flux cellulosic membrane in a random sequence. AFB is a haemodiafiltration technique based on a continuous post-dilution infusion of a sterile isotonic bicarbonate solution. At the start of the run-in period (and for the entire length of the study), rHuEpo administration was withdrawn; patients whose haemoglobin (Hb) levels dropped at a level <8.0 g/dl at one single monthly check, had to be withdrawn from the study. A blood sample was collected every month for the blood gas analysis and for the determination of blood urea nitrogen, serum creatinine, sodium, potassium, calcium, phosphorus, Hb, erythrocyte, reticulocyte, leukocyte and thrombocyte cell counts, mean globular volume and haematocrit. An equilibrated single pool Kt/V(urea)>1.2 was mandatory in both treatment modalities. Serum iron, total iron-binding capacity, and ferritin were checked every 3 months.
  
  
  RESULTS
  Twenty-three of 137 haemodialysis patients were considered eligible for the trial on the basis of the entry criteria. Of these, 15 volunteered and only 10 completed the study. No significant differences in the haematological indices, in the biochemical parameters assessing body iron stores, or in i.v. iron dosage was observed when comparing AFB with BD treatments. The equilibrated single pool Kt/V(urea) was always >1.2 and in no case was a significant difference observed when comparing AFB with BD treatments. Treatment time was significantly different between the two treatments (262+/-2 min in BD and 249+/-1 in AFB, P<0.0001). Neither pre- nor post-dialysis systolic and diastolic blood pressures, pre-dialysis serum bicarbonate and pH, pre-dialysis serum sodium, potassium, calcium, or phosphorus were significantly different when comparing the two treatment modalities. All 10 patients completed the 1-year follow-up without any major side-effects.
  
  
  CONCLUSIONS
  Our study did not show any improvement of anaemia when treating a highly selected patient group, in the absence of any Epo therapy, with AFB compared with standard BD. Even though these conclusions cannot be extended in toto to the entire dialysis population, in which there is a large proportion of Epo-treated patients with Hb levels around 11 g/dl, we may nevertheless conclude that when patients are well selected, adequately dialysed, and not iron- and/or vitamin-depleted, the effect of a haemodiafiltration technique with a high-flux biocompatible membrane is less than might be expected from the results of uncontrolled studies.
authors.affiliation: Nephrology and Dialysis Unit, Hospital of Martina Franca, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Basile
authors.forename: R
authors.initials: R
authors.lastname: Giordano
authors.forename: A
authors.initials: A
authors.lastname: Montanaro
authors.forename: P D
authors.initials: PD
authors.lastname: De Maio
authors.forename: F D
authors.initials: FD
authors.lastname: De Padova
authors.forename: A L
authors.initials: AL
authors.lastname: Marangi
authors.forename: A
authors.initials: A
authors.lastname: Semeraro
mesh_terms: D000085:Acetates; D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood / Q000209:etiology* / Q000628:therapy*; D001672:Biocompatible Materials; D018592:Cross-Over Studies; D017583:Hemodiafiltration; D006801:Humans; D007501:Iron / Q000097:blood; D008567:Membranes, Artificial; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects*
chemical_list: D000085:Acetates; D001672:Biocompatible Materials; D008567:Membranes, Artificial; D007501:Iron