Benefits of Hemodialysis With Citrate (ABC-treat) Study

Hemodialysis-Induced Symptom Clinical Trial

— ABC-treat  

Official title:

Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03319680
• Other study ID #: ABC-Treat
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: October 19, 2017
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2017
• Source: Fundación Senefro
• Contact: Patricia de Sequera, PhD
• Phone: 911918502
• Email: patricia.desequera[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis-Induced Symptom

Intervention

Other:
• Citrate dialysate
Compare the effect of citrate dialysate with acetate dialysate

Locations

Country	Name	City	State
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital Universitario Santa Lucía	Cartagena	Murcia
Spain	Hospital General de Castellón	Castelló de la Plana	Castellón
Spain	Hospital del Henares	Coslada	Madrid
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Universitary Hospital Infanta Leonor	Madrid
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Universitario Infanta Sofía	San Sebastian de los Reyes	Madrid
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital de Galdakao	Usansolo	Vizcaya

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Senefro	Baxter Healthcare Corporation

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

Grundström 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. — View 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. — View 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. Erratum in: Artif Organs. 2013 Aug;37(8):746. — View Citation

Molina Nuñez M, de Alarcón R, Roca S, Álvarez G, Ros MS, Jimeno C, Bucalo L, Villegas I, García MÁ. Citrate versus acetate-based dialysate in on-line haemodiafiltration. A prospective cross-over study. Blood Purif. 2015;39(1-3):181-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the effect of citrate dialysate with acetate dialysate on calcium level	Calcium (mg/dl) blood determination	32 weeks
Secondary	Compare the effect of citrate dialysate with acetate dialysate on phosphate level	Phosphate (mg/dl) blood determination	32 weeks
Secondary	Compare the effect of citrate dialysate with acetate dialysate on parathormone level.	Parathormone (pg/ml) blood determination	32 weeks
Secondary	Inflammation status by blood determination of IL-6	IL-6 (UI) blood determination	32 weeks
Secondary	Inflammation status by blood determination of us-PCR	us-PCR (UI) blood determination	32 weeks
Secondary	Inflammation status by blood determination of ERI	EPO Resistance Index (ERI) is calculated according to the following formula: ERI = EPO Dose (U/kg/week) / Hb (g/dl).	32 weeks
Secondary	Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Urea	Urea reduction rates (RR) will be calculated as: RR (%) = [(Cpre - post)/Cpre] x 100.; Where Cpre and Cpost are the concentrations of pre and post dialysis analyzed substances.	32 weeks
Secondary	Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin	ß2m reduction rates (RR) will be calculated as: RR (%) = [(Cpre - post)/Cpre] x 100.; Where Cpre and Cpost are the concentrations of pre and post dialysis analyzed substances.; ß2m concentrations at the end of the session will be corrected for concentration using a correction factor (FC) based on concentration of plasma proteins (PT): FC = PTpre/PTpost Where PTpre and PTpost are the concentrations of pre and post dialysis total proteins.	32 weeks
Secondary	Effect of citrate dialysate on the tolerance to the hemodialysis sessions by determining number of intradyalitic hypotensions	Compare the effect of citrate dialysate with acetate dialysate on reduction ratio (RR) of hypotensive episodes (clinical syntoms) during the hemodialysis sessions	32 weeks
Secondary	Effect of citrate dialysate on the nutritional parameters measured by biological parameters	Weight (Kg).	32 weeks
Secondary	Effect of citrate dialysate on the nutritional parameters measured by biological parameters	Normalized-protein catabolism rate corrected by body weight (PCR-n) is calculated using the following formula: PCRn = PCR/weight (kg) PCR= (9.35×G) + (0.00028×V) G: generation of interdialytic urea: G = [(C3-C2)×V]/2646 is the generation of interdialytic urea C2 = urea concentration at the end of hemodialysis C3 = urea concentration at the start of the following hemodialysis session parameters	32 weeks

External Links

•   Sponsor web page