Clinical trial NCT03319680: Benefits of Hemodialysis With Citrate (ABC-treat) Study
Official title: Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis-Induced Symptom
Lead sponsor: Fundación Senefro
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2017-10-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
timeFrame: 32 weeks
Secondary outcomes:
measure: Compare the effect of citrate dialysate with acetate dialysate on calcium level
timeFrame: 32 weeks
measure: Compare the effect of citrate dialysate with acetate dialysate on phosphate level
timeFrame: 32 weeks
measure: Compare the effect of citrate dialysate with acetate dialysate on parathormone level.
timeFrame: 32 weeks
measure: Inflammation status by blood determination of IL-6
timeFrame: 32 weeks
measure: Inflammation status by blood determination of us-PCR
timeFrame: 32 weeks
measure: Inflammation status by blood determination of ERI
timeFrame: 32 weeks
measure: Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea
timeFrame: 32 weeks
measure: Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin
timeFrame: 32 weeks
measure: Effect of citrate dialysate on the tolerance to the hemodialysis sessions by determining number of intradyalitic hypotensions
timeFrame: 32 weeks
measure: Effect of citrate dialysate on the nutritional parameters measured by biological parameters
timeFrame: 32 weeks
measure: Effect of citrate dialysate on the nutritional parameters measured by biological parameters
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
facility: Hospital General de Castellón
state: Castellón
city: Coslada
country: Spain
facility: Hospital del Henares
state: Madrid
city: San Sebastian de los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofía
state: Madrid
city: Cartagena
country: Spain
facility: Hospital Universitario Santa Lucía
state: Murcia
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Usansolo
country: Spain
facility: Hospital de Galdakao
state: Vizcaya
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Madrid
country: Spain
facility: Universitary Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Nephrology department. Hospital universitario Infanta Leonor
name: Rafael Perez-Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gabutti L, Lucchini B, Marone C, Alberio L, Burnier M. Citrate- vs. acetate-based dialysate in bicarbonate haemodialysis: consequences on haemodynamics, coagulation, acid-base status, and electrolytes. BMC Nephrol. 2009 Mar 5;10:7. doi: 10.1186/1471-2369-10-7.
citation: Kossmann RJ, Gonzales A, Callan R, Ahmad S. Increased efficiency of hemodialysis with citrate dialysate: a prospective controlled study. Clin J Am Soc Nephrol. 2009 Sep;4(9):1459-64. doi: 10.2215/CJN.02590409. Epub 2009 Aug 6.
citation: Bryland A, Wieslander A, Carlsson O, Hellmark T, Godaly G. Citrate treatment reduces endothelial death and inflammation under hyperglycaemic conditions. Diab Vasc Dis Res. 2012 Jan;9(1):42-51. doi: 10.1177/1479164111424297. Epub 2011 Nov 1.
citation: Daimon S, Dan K, Kawano M. Comparison of acetate-free citrate hemodialysis and bicarbonate hemodialysis regarding the effect of intra-dialysis hypotension and post-dialysis malaise. Ther Apher Dial. 2011 Oct;15(5):460-5. doi: 10.1111/j.1744-9987.2011.00976.x.
citation: Grundstrom G, Christensson A, Alquist M, Nilsson LG, Segelmark M. Replacement of acetate with citrate in dialysis fluid: a randomized clinical trial of short term safety and fluid biocompatibility. BMC Nephrol. 2013 Oct 9;14:216. doi: 10.1186/1471-2369-14-216.
citation: Molina Nunez M, de Alarcon R, Roca S, Alvarez G, Ros MS, Jimeno C, Bucalo L, Villegas I, Garcia MA. Citrate versus acetate-based dialysate in on-line haemodiafiltration. A prospective cross-over study. Blood Purif. 2015;39(1-3):181-187. doi: 10.1159/000371569.
citation: Kuragano T, Kida A, Furuta M, Yahiro M, Kitamura R, Otaki Y, Nonoguchi H, Matsumoto A, Nakanishi T. Effects of acetate-free citrate-containing dialysate on metabolic acidosis, anemia, and malnutrition in hemodialysis patients. Artif Organs. 2012 Mar;36(3):282-90. doi: 10.1111/j.1525-1594.2011.01349.x. Epub 2011 Sep 29.
citation: de Sequera Ortiz P, Perez Garcia R, Molina Nunez M, Munoz Gonzalez RI, Alvarez Fernandez G, Merida Herrero E, Camba Caride MJ, Blazquez Collado LA, Alcaide Lara MP, Echarri Carrillo R; en representacion del grupo del estudio ABC-treat; Grupo del estudio ABC-treat. Prospective randomised multicentre study to demonstrate the benefits of haemodialysis without acetate (with citrate): ABC-treat Study. Acute effect of citrate. Nefrologia (Engl Ed). 2019 Jul-Aug;39(4):424-433. doi: 10.1016/j.nefro.2018.11.002. Epub 2019 Jan 24. English, Spanish.