Prospective randomized cross-over multicenter study to demonstrate the benefits of hemodialysis without acetate dialysate, with citrate. 32 weeks duration, in two phases. In the first, half of the patients started with citrate dialysate for 16 weeks and the other half with acetate dialysate, and then patients cross. The primary objective is to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.
Primary objective: to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis. Secondary objectives: * Evaluate the effect of dialysate on the variation of calcium pre and post-dialytic, as well as on the parathormone (PTH) * Assess the effect of dialysate on inflammation * Assess the effect of dialysate on the Elimination of small and medium-sized molecules * Assess the effect of dialysate on the tolerance to the hemodialysis sessions * Assess the effect of dialysate on nutritional parameters Patients: Adult patients dialysed three times per week for at least 3 months will be enrolled in 12 Spanish dialysis centres. Catheter as vascular access will be excluded. Design: prospective randomized multicenter, cross-over trial of chronic haemodialysis patients to compare the effect of citrate dialysate with acetate dialysate. Duration of study: 32 weeks, in two phases. Randomised to 16 weeks of hemodialysis with acetate followed by 16 weeks of citrate or 16 weeks of hemodialysis with citrate followed by 16 weeks of acetate. Each patient will serve as control of itself and there will be no changes in the pattern of dialysis during the study with the exception of the dialysate, following the usual pattern of work
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Compare the effect of citrate dialysate with acetate dialysate
Hospital General de Castellón
Castellon, Castellón, Spain
RECRUITINGHospital del Henares
Coslada, Madrid, Spain
RECRUITINGEffect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
The anion gap will be calculated as: Anion gap = \[Na+\] - (\[Cl-\] + \[CO3H-\])
Time frame: 32 weeks
Compare the effect of citrate dialysate with acetate dialysate on calcium level
Calcium (mg/dl) blood determination
Time frame: 32 weeks
Compare the effect of citrate dialysate with acetate dialysate on phosphate level
Phosphate (mg/dl) blood determination
Time frame: 32 weeks
Compare the effect of citrate dialysate with acetate dialysate on parathormone level.
Parathormone (pg/ml) blood determination
Time frame: 32 weeks
Inflammation status by blood determination of IL-6
IL-6 (UI) blood determination
Time frame: 32 weeks
Inflammation status by blood determination of us-PCR
us-PCR (UI) blood determination
Time frame: 32 weeks
Inflammation status by blood determination of ERI
EPO Resistance Index (ERI) is calculated according to the following formula: ERI = EPO Dose (U/kg/week) / Hb (g/dl).
Time frame: 32 weeks
Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea
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Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
RECRUITINGHospital Universitario Santa Lucía
Cartagena, Murcia, Spain
RECRUITINGHospital de Basurto
Bilbao, Vizcaya, Spain
RECRUITINGHospital de Galdakao
Usansolo, Vizcaya, Spain
RECRUITINGHospital Universitario de Guadalajara
Guadalajara, Spain
RECRUITINGUniversitary Hospital Infanta Leonor
Madrid, Spain
RECRUITINGHospital Universitario 12 de Octubre
Madrid, Spain
RECRUITINGComplexo Hospitalario Universitario de Ourense
Ourense, Spain
RECRUITING...and 2 more locations
Urea reduction rates (RR) will be calculated as: RR (%) = \[(Cpre - post)/Cpre\] x 100. Where Cpre and Cpost are the concentrations of pre and post dialysis analyzed substances.
Time frame: 32 weeks
Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin
β2m reduction rates (RR) will be calculated as: RR (%) = \[(Cpre - post)/Cpre\] x 100. Where Cpre and Cpost are the concentrations of pre and post dialysis analyzed substances. β2m concentrations at the end of the session will be corrected for concentration using a correction factor (FC) based on concentration of plasma proteins (PT): FC = PTpre/PTpost Where PTpre and PTpost are the concentrations of pre and post dialysis total proteins.
Time frame: 32 weeks
Effect of citrate dialysate on the tolerance to the hemodialysis sessions by determining number of intradyalitic hypotensions
Compare the effect of citrate dialysate with acetate dialysate on reduction ratio (RR) of hypotensive episodes (clinical syntoms) during the hemodialysis sessions
Time frame: 32 weeks
Effect of citrate dialysate on the nutritional parameters measured by biological parameters
Weight (Kg).
Time frame: 32 weeks
Effect of citrate dialysate on the nutritional parameters measured by biological parameters
Normalized-protein catabolism rate corrected by body weight (PCR-n) is calculated using the following formula: PCRn = PCR/weight (kg) PCR= (9.35×G) + (0.00028×V) G: generation of interdialytic urea: G = \[(C3-C2)×V\]/2646 is the generation of interdialytic urea C2 = urea concentration at the end of hemodialysis C3 = urea concentration at the start of the following hemodialysis session parameters
Time frame: 32 weeks