Benefits of Hemodialysis With Citrate (ABC-treat) Study

Fundación Senefro

Status

Unknown

Conditions

Hemodialysis-Induced Symptom

Treatments

Other: Citrate dialysate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03319680

ABC-Treat

Details and patient eligibility

About

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.

Full 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

Enrollment

90 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.