title: Convection versus diffusion in dialysis: an Italian prospective multicentre study.
abstract: The concept of dialysis adequacy has to be widened to include medium size and large molecule removal in addition to urea kinetics. The HEMO study found a non-significant trend toward a beneficial effect on mortality of high-flux dialysis compared with low-flux dialysis. In that study, the beneficial effect of convection could have been attenuated by the fact that 'internal filtration' in high-flux haemodialysis (HD) is lower than that expected by convection in haemofiltration (HF) or haemodiafiltration (HDF). To explore the putative beneficial effect of convection, this Italian multicentre study was planned, comparing on-line convective treatments (HF and HDF) with standard, low-flux HD. The enrolled patients will be evaluated prospectively on their usual treatment for 2 months (baseline period) and subsequently randomized to continue either with low-flux HD (50%) or to start on-line convective treatment (50%), HF or HDF according to a 1:1 ratio. The primary end point of the study will be cardiovascular stability and blood pressure control. As secondary aims of the study, the impact on symptoms, morbidity and mortality will be assessed. Feasibility and patient compliance during HF and HDF treatments will also be evaluated. The experimental phase of the study, of at least 2 years, is divided into a 3-month adaptation period and a subsequent evaluation period. A recruitment period of 1 year is planned. The study design has adequate power to detect an absolute reduction of 3% hypotensive episodes with the experimental convective treatments compared with standard low-flux HD.
authors.affiliation: Departments of Nephrology and Dialysis, Unità Operativa: Servizio Dialisi Territoriale, Azienda USL N.8 di Cagliari, Italy. dialisiterritorio@tiscali.it
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Bolasco
authors.forename: Paolo
authors.initials: P
authors.lastname: Altieri
authors.forename: Simeone
authors.initials: S
authors.lastname: Andrulli
authors.forename: Carlo
authors.initials: C
authors.lastname: Basile
authors.forename: Salvatore
authors.initials: S
authors.lastname: Di Filippo
authors.forename: Mariano
authors.initials: M
authors.lastname: Feriani
authors.forename: Luciano
authors.initials: L
authors.lastname: Pedrini
authors.forename: Antonio
authors.initials: A
authors.lastname: Santoro
authors.forename: Carmine
authors.initials: C
authors.lastname: Zoccali
authors.forename: Giovanna
authors.initials: G
authors.lastname: Sau
authors.forename: Francesco
authors.initials: F
authors.lastname: Locatelli
mesh_terms: D018481:Convection; D003627:Data Interpretation, Statistical; D006440:Hemofiltration / Q000379:methods*; D006801:Humans; D007558:Italy; D007674:Kidney Diseases / Q000628:therapy*; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods*; D012107:Research Design; D018401:Sample Size