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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citrate dialysate | Active Comparator | Hemodialysis with citrate dialysate during 16 weeks |
|
| Acetate dialysate | No Intervention | Hemodialysis with acetate dialysate during 16 weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrate dialysate | Other | Compare the effect of citrate dialysate with acetate dialysate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effect of citrate dialysate with acetate dialysate on calcium level | Calcium (mg/dl) blood determination | 32 weeks |
| Compare the effect of citrate dialysate with acetate dialysate on phosphate level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia de Sequera, PhD | Contact | 911918502 | patricia.desequera@salud.madrid.org | |
| Manuel Molina, PhD | Contact | manuel.molina4@carm.es |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Perez-Garcia, PhD | Nephrology department. Hospital universitario Infanta Leonor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Castellón | Recruiting | Castellon | Castellón | 12004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19265544 | Background | 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. | |
| 19661218 | Background | 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. |
| Label | URL |
|---|---|
| Sponsor web page | View source |
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Phosphate (mg/dl) blood determination
| 32 weeks |
| Compare the effect of citrate dialysate with acetate dialysate on parathormone level. | Parathormone (pg/ml) blood determination | 32 weeks |
| Inflammation status by blood determination of IL-6 | IL-6 (UI) blood determination | 32 weeks |
| Inflammation status by blood determination of us-PCR | us-PCR (UI) blood determination | 32 weeks |
| 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 |
| 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 |
| Effect of citrate dialysate on the hemodialysis elimination of small and medium-sized in molecules using reduction ratio (RR) of Beta2-microglobulin | β2m 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. β2m 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 |
| 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 |
| Effect of citrate dialysate on the nutritional parameters measured by biological parameters | Weight (Kg). | 32 weeks |
| 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 |
| Hospital del Henares | Recruiting | Coslada | Madrid | 28822 | Spain |
|
| Hospital Universitario Infanta Sofía | Recruiting | San Sebastián de los Reyes | Madrid | 28702 | Spain |
|
| Hospital Universitario Santa Lucía | Recruiting | Cartagena | Murcia | 30202 | Spain |
|
| Hospital de Basurto | Recruiting | Bilbao | Vizcaya | 48013 | Spain |
|
| Hospital de Galdakao | Recruiting | Usansolo | Vizcaya | 48960 | Spain |
|
| Hospital Universitario de Guadalajara | Recruiting | Guadalajara | 19002 | Spain |
|
| Universitary Hospital Infanta Leonor | Recruiting | Madrid | 28030 | Spain |
|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
|
| Complexo Hospitalario Universitario de Ourense | Recruiting | Ourense | 32205 | Spain |
|
| Hospital Universitario Virgen de la Macarena | Recruiting | Seville | 41009 | Spain |
|
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
|
| 22045866 | Background | 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. |
| 21974699 | Background | 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. |
| 24103587 | Background | 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. |
| 25791278 | Background | 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. |
| 21954915 | Background | 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. |
| 38189593 | Derived | 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. |
| 30686542 | Derived | 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. |