Estudio prospectivo aleatorizado multicéntrico para demostrar los beneficios de la hemodiálisis sin acetato (con citrato): Estudio ABC-treat. Efecto agudo del citrato / Prospective randomised multicentre study to demonstrate the benefits of haemodialysis without acetate (with citrate): ABC-treat Study. Acute effect of citrate

INTRODUCCIÓN: El líquido de diálisis (LD), elemento esencial en la hemodiálisis (HD), se fabrica in situ mezclando 3 componentes: agua tratada, concentrado de bicarbonato y concentrado ácido. Para evitar la precipitación de carbonato cálcico y magnésico que se produce en el LD por la adición de bicarbonato, es necesario añadir un ácido. Existen 2 concentrados ácidos según contengan acetato (LDA) o citrato (LDC) como estabilizante. OBJETIVO: Comparar el efecto agudo de la HD con LDC vs. LDA sobre el metabolismo del calcio, fosforo y magnesio, el equilibrio ácido base, la coagulación, inflamación y la estabilidad hemodinámica. MÉTODOS: Estudio prospectivo, multicéntrico, aleatorizado y cruzado, de 32 semanas de duración, en pacientes en HD trisemanal, monitor AK-200-Ultra-S o Artis, 16 semanas con LDA SoftPac(R), elaborado con 3 mmol/l de acetato, y 16 semanas con LDC SelectBag Citrate(R), con 1 mmol/l de citrato. Se incluyeron pacientes mayores de 18 años en HD durante un mínimo de 3 meses mediante fístula arteriovenosa. Se recogieron datos epidemiológicos, de diálisis, bioquímica pre- y posdiálisis, episodios de hipotensión arterial, y scores de coagulación mensualmente durante los 8 meses de estudio. Se extrajeron pre- y posdiálisis: gasometría venosa, calcio (Ca), calcio iónico (Cai), fósforo (P), magnesio (Mg) y hormona paratiroidea (PTH), entre otros. ClinicalTrials.gov NCT03319680. RESULTADOS: Se incluyeron 56 pacientes, 47 (84%) hombres y 9 (16%) mujeres de edad media: 65,3 (16,4) años, técnica HD / HDF: 20 (35,7%) / 36 (64,3%). Encontramos diferencias (p < 0,05) cuando utilizamos el LD con citrato (C) frente a acetato (A) en los valores posdiálisis de bicarbonato [C: 26,9 (1,9) vs. A: 28,5 (3) mmol/l], Cai [C: 1,1 (0,05) vs A: 1,2 (0,08) mmol/l], Mg [C. 1,8 (0,1) vs A: 1,9 (0,2) mg/dl] y PTH [C: 255 (172) vs. 148 (149) pg/ml]. No encontramos diferencias en ninguno de los parámetros medidos prediálisis. Se registraron menos episodios de hipotensión arterial durante las sesiones con el LDC; de las 4.416 sesiones de HD, 2.208 en cada grupo, cursaron con hipotensión 311 sesiones (14,1%) con LDA y 238 (10,8%) con LDC (p < 0,01). También fue menor la caída de volumen sanguíneo máximo medido por biosensor Hemoscan(R) [-3,4(7,7) vs. -5,1 (8,2)], aunque sin significación estadística. CONCLUSIÓN: La diálisis con citrato produce de forma aguda menor alcalemia posdiálisis y modifica de forma significativa el Ca, el Mg y la PTH. El LDC tiene un impacto positivo sobre la tolerancia hemodinámica

INTRODUCTION: Dialysis fluid (DF), an essential element in hemodialysis (HD), is manufactured in situ by mixing three components: treated water, bicarbonate concentrate and acid concentrate. To avoid the precipitation of calcium and magnesium carbonate that is produced in DF by the addition of bicarbonate, it is necessary to add an acid. There are 2 acid concentrates that contain acetate (ADF) or citrate (CDF) as a stabilizer. OBJECTIVE: To compare the acute effect of HD with CDF vs. ADF on the metabolism of calcium, phosphorus and magnesium, acid base balance, coagulation, inflammation and hemodynamic stability. METHODS: Prospective, multicenter, randomized and crossed study, of 32 weeks duration, in patients in three-week HD, AK-200-Ultra-S or Artis monitor, 16 weeks with ADF SoftPac(R), prepared with 3mmol/L of acetate, and 16 weeks with CDF SelectBag Citrate(R), with 1mmol/L of citrate. Patients older than 18 years were included in HD for a minimum of 3 months by arteriovenous fistula. Epidemiological, dialysis, pre and postdialysis biochemistry, episodes of arterial hypotension, and coagulation scores were collected monthly during the 8 months of the study. Pre and post-dialysis analysis were extracted: venous blood gas, calcium (Ca), ionic calcium (Cai), phosphorus (P), magnesium (Mg) and parathyroid hormone (PTH) among others. ClinicalTrials.gov NCT03319680. RESULTS: We included 56 patients, 47 (84%) men and 9 (16%) women, mean age: 65.3 (16.4) years, technique HD / HDF: 20 (35.7%) / 36 (64.3%). We found differences (p < 0.05) when using the DF with citrate (C) versus acetate (A) in the postdialysis values of bicarbonate [C: 26.9 (1.9) vs. A: 28.5 (3) mmol/L], Cai [C: 1.1 (0.05) vs. A: 1.2 (0.08) mmol/L], Mg [C: 1.8 (0.1) vs A: 1, 9 (0.2) mg/dL] and PTH [C: 255 (172) vs. 148 (149) pg/mL]. We did not find any differences in any of the parameters measured before dialysis. Of the 4,416 sessions performed, 2,208 in each group, 311 sessions (14.1%) with ADF and 238 (10.8%) with CDF (p < 0.01), were complicated by arterial hypotension. The decrease in maximum blood volume measured by Hemoscan(R) biosensor was also lower [-3.4 (7.7) vs -5.1 (8.2)] although without statistical significance. CONCLUSION: Dialysis with citrate acutely produces less postdialysis alkalemia and significantly modifies Ca, Mg and PTH. CDF has a positive impact on hemodynamic tolerance

Prospective randomised multicentre study to demonstrate the benefits of haemodialysis without acetate (with citrate): ABC-treat Study. Acute effect of citrate. / Estudio prospectivo aleatorizado multicéntrico para demostrar los beneficios de la hemodiálisis sin acetato (con citrato): Estudio ABC-treat. Efecto agudo del citrato.

INTRODUCTION: Dialysis fluid (DF), an essential element in hemodialysis (HD), is manufactured in situ by mixing three components: treated water, bicarbonate concentrate and acid concentrate. To avoid the precipitation of calcium and magnesium carbonate that is produced in DF by the addition of bicarbonate, it is necessary to add an acid. There are 2 acid concentrates that contain acetate (ADF) or citrate (CDF) as a stabilizer. OBJECTIVE: To compare the acute effect of HD with CDF vs. ADF on the metabolism of calcium, phosphorus and magnesium, acid base balance, coagulation, inflammation and hemodynamic stability. METHODS: Prospective, multicenter, randomized and crossed study, of 32 weeks duration, in patients in three-week HD, AK-200-Ultra-S or Artis monitor, 16 weeks with ADF SoftPac®, prepared with 3mmol/L of acetate, and 16 weeks with CDF SelectBag Citrate®, with 1mmol/L of citrate. Patients older than 18 years were included in HD for a minimum of 3 months by arteriovenous fistula. Epidemiological, dialysis, pre and postdialysis biochemistry, episodes of arterial hypotension, and coagulation scores were collected monthly during the 8 months of the study. Pre and post-dialysis analysis were extracted: venous blood gas, calcium (Ca), ionic calcium (Cai), phosphorus (P), magnesium (Mg) and parathyroid hormone (PTH) among others. ClinicalTrials.gov NCT03319680. RESULTS: We included 56 patients, 47 (84%) men and 9 (16%) women, mean age: 65.3 (16.4) years, technique HD/HDF: 20 (35.7%)/36 (64.3%). We found differences (p<0.05) when using the DF with citrate (C) versus acetate (A) in the postdialysis values of bicarbonate [C: 26.9 (1.9) vs. A: 28.5 (3) mmol/L], Cai [C: 1.1 (0.05) vs. A: 1.2 (0.08) mmol/L], Mg [C: 1.8 (0.1) vs A: 1, 9 (0.2) mg/dL] and PTH [C: 255 (172) vs. 148 (149) pg/mL]. We did not find any differences in any of the parameters measured before dialysis. Of the 4,416 sessions performed, 2,208 in each group, 311 sessions (14.1%) with ADF and 238 (10.8%) with CDF (p<0.01), were complicated by arterial hypotension. The decrease in maximum blood volume measured by Hemoscan® biosensor was also lower [-3.4 (7.7) vs -5.1 (8.2)] although without statistical significance. CONCLUSION: Dialysis with citrate acutely produces less postdialysis alkalemia and significantly modifies Ca, Mg and PTH. CDF has a positive impact on hemodynamic tolerance.