Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemodialysis-Induced Symptom
- Sponsor
- Fundación Senefro
- Enrollment
- 90
- Locations
- 12
- Primary Endpoint
- Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
Time Frame: 32 weeks
The anion gap will be calculated as: Anion gap = \[Na+\] - (\[Cl-\] + \[CO3H-\])
Secondary Outcomes
- Compare the effect of citrate dialysate with acetate dialysate on calcium level(32 weeks)
- Compare the effect of citrate dialysate with acetate dialysate on phosphate level(32 weeks)
- Compare the effect of citrate dialysate with acetate dialysate on parathormone level.(32 weeks)
- Inflammation status by blood determination of IL-6(32 weeks)
- Inflammation status by blood determination of us-PCR(32 weeks)
- Inflammation status by blood determination of ERI(32 weeks)
- Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea(32 weeks)
- Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin(32 weeks)
- Effect of citrate dialysate on the tolerance to the hemodialysis sessions by determining number of intradyalitic hypotensions(32 weeks)
- Effect of citrate dialysate on the nutritional parameters measured by biological parameters(32 weeks)