Benefits of Hemodialysis With Citrate (ABC-treat) Study
ABC-treat
Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study
1 other identifier
interventional
90
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 24, 2017
October 1, 2017
1.4 years
March 31, 2017
October 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session.
The anion gap will be calculated as: Anion gap = \[Na+\] - (\[Cl-\] + \[CO3H-\])
32 weeks
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
Citrate dialysate
ACTIVE COMPARATORHemodialysis with citrate dialysate during 16 weeks
Acetate dialysate
NO INTERVENTIONHemodialysis with acetate dialysate during 16 weeks
Interventions
Compare the effect of citrate dialysate with acetate dialysate
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundación Senefrolead
- Baxter Healthcare Corporationcollaborator
Study Sites (12)
Hospital General de Castellón
Castellon, Castellón, 12004, Spain
Hospital del Henares
Coslada, Madrid, 28822, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Universitario Santa Lucía
Cartagena, Murcia, 30202, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital de Galdakao
Usansolo, Vizcaya, 48960, Spain
Hospital Universitario de Guadalajara
Guadalajara, 19002, Spain
Universitary Hospital Infanta Leonor
Madrid, 28030, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, 32205, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Related Publications (9)
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.
PMID: 19265544BACKGROUNDKossmann 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.
PMID: 19661218BACKGROUNDBryland 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.
PMID: 22045866BACKGROUNDDaimon 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.
PMID: 21974699BACKGROUNDGrundstrom 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.
PMID: 24103587BACKGROUNDMolina 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.
PMID: 25791278BACKGROUNDKuragano 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.
PMID: 21954915BACKGROUNDNatale 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.
PMID: 38189593DERIVEDde 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.
PMID: 30686542DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Perez-Garcia, PhD
Nephrology department. Hospital universitario Infanta Leonor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
October 24, 2017
Study Start
May 1, 2016
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
October 24, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share