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.

Citrate versus acetate-based dialysate in on-line haemodiafiltration. A prospective cross-over study.

BACKGROUND AND AIMS: A bicarbonate dialysate acidified with citrate (CD) has been reported to have local anticoagulant effect and improves biocompatibility. This study examines the effect of CD on dialysis efficiency, coagulation, acid-base status, electrolytes, and inflammation in patients in on-line hemodiafiltration (OL-HDF). METHODS: 35 patients in OL-HDF were enrolled in a prospective, cross-over study for a 24-week period and two phases alternating CD and acetate dialysate fluid (AD). Parameters on study were predialysis levels of bicarbonate and ionic calcium, reactive C Protein (CRP), and beta-2 microglobulin (B2MG) and postdialysis levels of activated tromboplastine time, bicarbonate, and ionized calcium. RESULTS: No significant differences in coagulation parameters, pH, and predialysis bicarbonate were found. The postdialysis bicarbonate and postdialysis calcium were lower with CD. Dialysis efficiency was greater with CD. Regarding inflammatory parameters, both CRP and B2MG were lower using CD. CONCLUSION: The use of CD is safe and effective in OL-HDF, and it improves dialysis efficacy, postdialysis alkalosis, and inflammation.

[New reliable methods for the diagnose of protein-energy wasting in hemodialysis patients]. / Nuevos métodos fiables para diagnosticar la depleción proteico-calórica en los pacientes en hemodiálisis.

BACKGROUND: Protein-energy wasting (PEW), defined as the body loss of muscle mass and fat, is an important cardiovascular risk factor in dialysis patients. Diagnosing this condition requires the presence of three characteristics: biochemical (low albumine, prealbumine or cholesterol), body mass reduction (body mass index, weight loss or fat loss) and muscle mass reduction (measured by means of creatinine or arm muscle area). This study aimed at demonstrating that the lean tissue index (LTI) calculated by spectroscopic bioimpedance (SBI) is a valid parameter for the diagnostic of protein-energy wasting. METHODS: Cross-sectional study including 1369 patients with two BCM measurements on a six-month delay, analyzing analytic and spectroscopic bioimpedance parameters. RESULTS: The lean tissue index from the BCM (Body Composition Monitor) quantifies the patient's lean mass and it is matched against traditional parameters (plasma albumine) and non-traditional parameters (IRE and PCR) for protein-energy wasting with no alterations from the patient's hydration level. CONCLUSIONS: LTI is an easy to obtain parameter of lean mass which can be followed and monitored in order to diagnose risk situations of our patients as it is the protein- energy wasting.

Introducción: La depleción proteico-calórica (protein- energy wasting, PEW) definida como pérdida de masa muscular y grasa del organismo, supone un importante factor de riesgo cardiovascular en los pacientes en diálisis. Para su diagnóstico se requiere de la presencia de tres características: bioquímicas (albúmina, prealbúmina o colesterol bajos), descenso de masa corporal (índice de masa corporal, pérdida de peso o de grasa) y reducción de masa muscular (evaluada mediante creatinina o área muscular del brazo). El Objetivo del presente estudio es demostrar que el índice de tejido magro (LTI) obtenido por bioimpedancia espectroscópica (BIS) es un parámetro válido para el diagnóstico de depleción proteico- calórica. Métodos: Estudio transversal de 1369 pacientes con dos mediciones de BCM entre las que transcurren seis meses, en los que analizamos parámetros analíticos y de bioimpedancia espectroscópica . Resultados: El índice de tejido magro aportado por el BCM (Body Composition Monitor) cuantifica la masa magra del paciente y se correlaciona con parámetros tradicionales (albúmina plasmática) y no-tradicionales (IRE y PCR) de depleción proteico-calórica sin verse alterado por la situación hídrica del paciente. Conclusiones: El LTI es un parámetro de masa magra fácil de obtener cuyo seguimiento y monitorización nos puede ayudar a diagnosticar situaciones de riesgo para nuestros pacientes como la depleción proteico-calórica.

Nuevos métodos fiables para diagnosticar la depleción proteico-calórica en los pacientes en hemodiálisis / New reliable methods for the diagnose of protein-energy wasting in hemodialysis patients

Introducción: La depleción proteico-calórica (protein-energy wasting, PEW) definida como pérdida de masa muscular y grasa del organismo, supone un importante factor de riesgo cardiovascular en los pacientes en diálisis. Para su diagnóstico se requiere de la presencia de tres características: bioquímicas (albúmina, prealbúmina o colesterol bajos), descenso de masa corporal (índice de masa corporal, pérdida de peso o de grasa) y reducción de masa muscular (evaluada mediante creatinina o área muscular del brazo). El Objetivo del presente estudio es demostrar que el índice de tejido magro (LTI) obtenido por bioimpedancia espectroscópica (BIS) es un parámetro válido para el diagnóstico de depleción proteico-calórica. Métodos: Estudio transversal de 1369 pacientes con dos mediciones de BCM entre las que transcurren seis meses, en los que analizamos parámetros analíticos y de bioimpedancia espectroscópica . Resultados: El índice de tejido magro aportado por el BCM (Body Composition Monitor) cuantifica la masa magra del paciente y se correlaciona con parámetros tradicionales (albúmina plasmática) y no-tradicionales (IRE y PCR) de depleción proteico-calórica sin verse alterado por la situación hídrica del paciente. Conclusiones: El LTI es un parámetro de masa magra fácil de obtener cuyo seguimiento y monitorización nos puede ayudar a diagnosticar situaciones de riesgo para nuestros pacientes como la depleción proteico-calórica (AU)

Background: Protein-energy wasting (PEW), defined as the body loss of muscle mass and fat, is an important cardiovascular risk factor in dialysis patients. Diagnosing this condition requires the presence of three characteristics: biochemical (low albumine, prealbumine or cholesterol), body mass reduction (body mass index, weight loss or fat loss) and muscle mass reduction (measured by means of creatinine or arm muscle area). This study aimed at demonstrating that the lean tissue index (LTI) calculated by spectroscopic bioimpedance (SBI) is a valid parameter for the diagnostic of protein-energy wasting. Methods: Cross-sectional study including 1369 patients with two BCM measurements on a six-month delay, analyzing analytic and spectroscopic bioimpedance parameters. Results: The lean tissue index from the BCM (Body Composition Monitor) quantifies the patient’s lean mass and it is matched against traditional parameters (plasma albumine) and non-traditional parameters (IRE and PCR) for protein-energy wasting with no alterations from the patient’s hydration level. Conclusions: LTI is an easy to obtain parameter of lean mass which can be followed and monitored in order to diagnose risk situations of our patients as it is the protein-energy wasting (AU)

Fístulas espontáneas en extremidades superiores: a propósito de un caso / Spontaneous fistulae in the arms: a case study

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Epidemiological study of 7316 patients on haemodialysis treated in FME clinics in Spain, using data from the EuCliD® database: results from years 2009-2010.

Observational study of patients on hemodialysis (HD) in FMC® Spain clinics over the years 2009 and 2010. The data were collected from the EuClid® database, implemented in the clinics of FMC®, which complies with the following feature: record online, compulsory, conducted in patients incidents and that it covers the entire population on HD in these clinics. Its aim is to understand the characteristics of patients and treatment patterns, comparing them with other studies described in the literature and in order to improve their prognosis and quality of life. Include 2637 incidents patients and 4679 prevalent, which makes a total of 7316 patients. In prevalent patients: 24.4% were diabetic; 76.3% had cardio-vascular disease (CVD) and 13.4% cancer. Among the incidents, these percentages were: 33.5% diabetic; 80.6% had CVD and 12.6% cancer. The prevalent patients had such as vascular access: FAV 68.5%, prosthesis 5.6%, permanent catheter 23.7% and 2.3% temporary catheter. The average of the duration of the sessions of HD was 230 minutes. 23.2% of the prevalent patients were on on-line hemodiafiltration. These patients hospitalization rates were 0.46 hospitalizations per incident patient per year and 0.52 per prevalent patient per year. The annual gross mortality rate was 12%. The mortality of the patients in this study HD is smaller than these of the Spanish Registry of Dialysis and Transplant (GRER). The result of morbidity and mortality of the FMC clinics of Spain can, therefore, be as good compared with these of the GRER and other international series. That does not mean that there are not areas of improvement as the increase in the time of dialysis, the percentage of patients on on-line hemodiafiltration convective techniques and the percentage of FAV.