Jacky Potier1, Thibault Dolley-Hitze2, Didier Hamel2, Isabelle Landru3, Erick Cardineau4, Guillaume Queffeulou1, Elie Zagdoun5, Eric Renaudineau6, Nicolas Molinari7, Lucie Gamon8, Marion Morena9, Jean-Paul Cristol9,10, Bernard Canaud11,12. 1. Department of Nephrology and Hemodialysis, Centre Hospitalier Public du Cotentin, Cherbourg, France. 2. AUB Santé, Dialysis Unit, Saint-Malo, France. 3. Department of Nephrology and Hemodialysis, Centre Hospitalier Robert Bisson, Lisieux, France. 4. Department of Nephrology and Hemodialysis, Centre Hospitalier Intercommunal Alencon-Mamers, Alençon, France. 5. Department of Nephrology and Hemodialysis, Centre Hospitalier Mémorial France Etats-Unis, Saint-Lô, France. 6. Department of Nephrology and Hemodialysis, Centre Hospitalier Broussais, Saint-Malo, France. 7. IMAG, CNRS, Centre Hospitalier Universitaire de Montpellier, University of Montpellier, Montpellier, France. 8. Clinical Research and Epidemiology Unit, Centre Hospitalier Universitaire de Montpellier, University of Montpellier, Montpellier, France. 9. PhyMedExp. INSERM, CNRS, Université de Montpellier, Montpellier, France. 10. Département de Biochimie et Hormonologie, Centre Hospitalier Universitaire de Montpellier, Montpellier, France. 11. School of Medicine, Montpellier University, Montpellier, France. 12. FMC, Global Medical Office, Bad Homburg, Germany.
Abstract
BACKGROUND: Citric acid-based bicarbonate haemodialysis (CIT-HD) has gained more clinical acceptance over the last few years in France and is a substitute for other acidifiers [e.g. acetic acid (CH3COOH) and hydrochloric acid (HCl)]. This trend was justified by several clinical benefits compared with CH3COOH as well as the desire to avoid the consequences of the corrosive action of HCl, but a nationwide clinical report raised concerns about the long-term safety of CIT-HD. The aim of this study was to assess the long-term effects of CIT-HD exposure on patient outcomes in western France. METHODS: This is a population-based retrospective multicentre observational study performed in 1132 incident end-stage kidney disease patients in five sanitary territories in western France who started their renal replacement therapy after 1 January 2008 and followed up through 15 October 2018. Relevant data, collected prospectively with the same medical software, were anonymously aggregated for the purposes of the study. The primary goal of this study was to investigate the effects of citrate exposure on all-cause mortality. To provide a control group to CIT-HD one, propensity score matching (PSM) at 2:1 was performed in two steps: the first analysis was intended to be exploratory, comparing patients who received citrate ≤80% of the time (CIT-HD ≤80) versus those who received citrate >80% of the time (CIT-HD >80), while the second analysis was intended to be explanatory in comparing patients with 0% (CIT-HD0) versus 100% citrate time exposure (CIT-HD100). RESULTS: After PSM, in the exploratory part of the analysis, 432 CIT-HD ≤80 patients were compared with 216 CIT-HD >80 patients and no difference was found for all-cause mortality using the Kaplan-Meier model (log-rank 0.97), univariate Cox regression analysis {hazard ratio [HR] 1.01 [95% confidence interval (CI) 0.71-1.40]} and multivariate Cox regression analysis [HR 1.11 (95% CI 0.76-1.61)] when adjusted for nine variables with clinical pertinence and high statistical relevance in the univariate analysis. In the explanatory part of the analysis, 316 CIT-HD0 patients were then compared with 158 CIT-HD100 patients and no difference was found using the Kaplan-Meier model (log-rank 0.06), univariate Cox regression analysis [HR 0.69 (95% CI 0.47-1.03)] and multivariate Cox regression analysis [HR 0.87 (95% CI 0.57-1.33)] when adjusted for seven variables with clinical pertinence and high statistical relevance in the univariate analysis. CONCLUSIONS: Findings of this study support the notion that CIT-HD exposure ≤6 years has no significant effect on all-cause mortality in HD patients. This finding remains true for patients receiving high-volume online haemodiafiltration, a modality most frequently prescribed in this cohort.
BACKGROUND:Citric acid-based bicarbonate haemodialysis (CIT-HD) has gained more clinical acceptance over the last few years in France and is a substitute for other acidifiers [e.g. acetic acid (CH3COOH) and hydrochloric acid (HCl)]. This trend was justified by several clinical benefits compared with CH3COOH as well as the desire to avoid the consequences of the corrosive action of HCl, but a nationwide clinical report raised concerns about the long-term safety of CIT-HD. The aim of this study was to assess the long-term effects of CIT-HD exposure on patient outcomes in western France. METHODS: This is a population-based retrospective multicentre observational study performed in 1132 incident end-stage kidney diseasepatients in five sanitary territories in western France who started their renal replacement therapy after 1 January 2008 and followed up through 15 October 2018. Relevant data, collected prospectively with the same medical software, were anonymously aggregated for the purposes of the study. The primary goal of this study was to investigate the effects of citrate exposure on all-cause mortality. To provide a control group to CIT-HD one, propensity score matching (PSM) at 2:1 was performed in two steps: the first analysis was intended to be exploratory, comparing patients who received citrate ≤80% of the time (CIT-HD ≤80) versus those who received citrate >80% of the time (CIT-HD >80), while the second analysis was intended to be explanatory in comparing patients with 0% (CIT-HD0) versus 100% citrate time exposure (CIT-HD100). RESULTS: After PSM, in the exploratory part of the analysis, 432 CIT-HD ≤80 patients were compared with 216 CIT-HD >80 patients and no difference was found for all-cause mortality using the Kaplan-Meier model (log-rank 0.97), univariate Cox regression analysis {hazard ratio [HR] 1.01 [95% confidence interval (CI) 0.71-1.40]} and multivariate Cox regression analysis [HR 1.11 (95% CI 0.76-1.61)] when adjusted for nine variables with clinical pertinence and high statistical relevance in the univariate analysis. In the explanatory part of the analysis, 316 CIT-HD0 patients were then compared with 158 CIT-HD100 patients and no difference was found using the Kaplan-Meier model (log-rank 0.06), univariate Cox regression analysis [HR 0.69 (95% CI 0.47-1.03)] and multivariate Cox regression analysis [HR 0.87 (95% CI 0.57-1.33)] when adjusted for seven variables with clinical pertinence and high statistical relevance in the univariate analysis. CONCLUSIONS: Findings of this study support the notion that CIT-HD exposure ≤6 years has no significant effect on all-cause mortality in HDpatients. This finding remains true for patients receiving high-volume online haemodiafiltration, a modality most frequently prescribed in this cohort.
Authors: Pablo Ureña-Torres; Brian Bieber; Fitsum Guebre-Egziabher; Rim Ossman; Michel Jadoul; Masaaki Inaba; Bruce M Robinson; Friedrich Port; Christian Jacquelinet; Christian Combe Journal: Kidney360 Date: 2021-02-04