Benefits of Hemodialysis With Citrate (ABC-treat) Study
NCT ID: NCT03319680
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
90 participants
INTERVENTIONAL
2016-05-31
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Citrate dialysate
Hemodialysis with citrate dialysate during 16 weeks
Citrate dialysate
Compare the effect of citrate dialysate with acetate dialysate
Acetate dialysate
Hemodialysis with acetate dialysate during 16 weeks
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Citrate dialysate
Compare the effect of citrate dialysate with acetate dialysate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Arteriovenous fistula as vascular access
* Patients who have given their informed consent in writing.
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Baxter Healthcare Corporation
INDUSTRY
Fundación Senefro
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rafael Perez-Garcia, PhD
Role: PRINCIPAL_INVESTIGATOR
Nephrology department. Hospital universitario Infanta Leonor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital General de Castellón
Castellon, Castellón, Spain
Hospital del Henares
Coslada, Madrid, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Hospital Universitario Santa Lucía
Cartagena, Murcia, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital de Galdakao
Usansolo, Vizcaya, Spain
Hospital Universitario de Guadalajara
Guadalajara, , Spain
Universitary Hospital Infanta Leonor
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Complexo Hospitalario Universitario de Ourense
Ourense, , Spain
Hospital Universitario Virgen de la Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ramón Pons
Role: primary
Blanca Bueno
Role: primary
Rocio Echarri
Role: primary
Gracia Alvarez
Role: primary
Iñigo Moina
Role: primary
Rosa Inés Muñoz
Role: primary
Gabriel De Arriba
Role: primary
Patricia de Sequera, PhD
Role: primary
Eva Mérida
Role: primary
Alfoso Otero
Role: primary
Rocío Valverde
Role: primary
Luis Gil
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Sponsor web page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ABC-Treat
Identifier Type: -
Identifier Source: org_study_id