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

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started May 2016

Geographic Reach

1 country

12 active sites

Status

unknown

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

1.6 years study duration

Study Start

First participant enrolled

May 1, 2016

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed

23 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

March 31, 2017

Last Update Submit

October 19, 2017

Conditions

Hemodialysis-Induced Symptom

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 COMPARATOR

Hemodialysis with citrate dialysate during 16 weeks

Other: Citrate dialysate

Acetate dialysate

NO INTERVENTION

Hemodialysis with acetate dialysate during 16 weeks

Interventions

Citrate dialysateOTHER

Compare the effect of citrate dialysate with acetate dialysate

Also known as: Acetate dialysate

Citrate dialysate

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Hospital del Henares

Coslada, Madrid, 28822, Spain

RECRUITING

Hospital Universitario Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

RECRUITING

Hospital Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

RECRUITING

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

RECRUITING

Hospital de Galdakao

Usansolo, Vizcaya, 48960, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, 19002, Spain

RECRUITING

Universitary Hospital Infanta Leonor

Madrid, 28030, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, 32205, Spain

RECRUITING

Hospital Universitario Virgen de la Macarena

Seville, 41009, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

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: 19265544BACKGROUND
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.
PMID: 19661218BACKGROUND
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.
PMID: 22045866BACKGROUND
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.
PMID: 21974699BACKGROUND
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.
PMID: 24103587BACKGROUND
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.
PMID: 25791278BACKGROUND
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.
PMID: 21954915BACKGROUND
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.
PMID: 38189593DERIVED
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.
PMID: 30686542DERIVED

Study Officials

Rafael Perez-Garcia, PhD
Nephrology department. Hospital universitario Infanta Leonor
PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia de Sequera, PhD

CONTACT

911918502 patricia.desequera@salud.madrid.org

Manuel Molina, PhD

CONTACT

manuel.molina4@carm.es

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

Locations

ES(12)

Benefits of Hemodialysis With Citrate (ABC-treat) Study

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Citrate dialysate

Acetate dialysate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (9)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (2)

Citrate dialysate

Acetate dialysate

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Publications (9)

Related Links

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations