Benefits of Hemodialysis With Citrate (ABC-treat) Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study

Conditions
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Hemodialysis-Induced Symptom

Intervention / Treatment
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* Other: Citrate dialysate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient conventional hemodialysis three times per week for at least three months. Arteriovenous fistula as vascular access Patients who have given their informed consent in writing. Exclusion Criteria: Catheter as vascular access Allergy or intolerance to citrate Patients with sufficient cognitive impairment that would prevent the compression of information and informed consent. Inflammatory intercurrent diseases (chronic infections, autoimmune diseases or tumors) that can mask the results of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Citrate dialysate<br>Hemodialysis with citrate dialysate during 16 weeks | Other: Citrate dialysate<br>* Compare the effect of citrate dialysate with acetate dialysate<br>* Other names: Acetate dialysate;|
| No Intervention: Acetate dialysate<br>Hemodialysis with acetate dialysate during 16 weeks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect 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-]) | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of citrate dialysate with acetate dialysate on calcium level | Calcium (mg/dl) blood determination | 32 weeks | 
| Compare the effect of citrate dialysate with acetate dialysate on phosphate level | Phosphate (mg/dl) blood determination | 32 weeks | 
| Compare the effect of citrate dialysate with acetate dialysate on parathormone level. | Parathormone (pg/ml) blood determination | 32 weeks | 
| Inflammation status by blood determination of IL-6 | IL-6 (UI) blood determination | 32 weeks | 
| Inflammation status by blood determination of us-PCR | us-PCR (UI) blood determination | 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). | 32 weeks | 
| Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea | 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. | 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. | 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 | 32 weeks | 
| Effect of citrate dialysate on the nutritional parameters measured by biological parameters | Weight (Kg). | 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 | 32 weeks |