NCT03319680

Benefits of Hemodialysis With Citrate (ABC-treat) Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Fundación Senefro · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemodialysis-Induced Symptom

Interventions

Type	Name	Description
OTHER	Citrate dialysate	Compare the effect of citrate dialysate with acetate dialysate

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2017-10-24
• Last updated: 2017-10-24

Locations

12 sites across 1 country: Spain