Francesco Pizzarelli1, Vincenzo Cantaluppi2, Vincenzo Panichi3, Alessandro Toccafondi4, Giuseppe Ferro4, Serena Farruggio2, Elena Grossini5, Pietro Claudio Dattolo4, Vincenzo Miniello6, Massimiliano Migliori3, Cristina Grimaldi7, Aldo Casani8, Maurizio Borzumati9, Stefano Cusinato10, Alessandro Capitanini6, Alessandro Quercia11, Oliviero Filiberti12, Lucia Dani13. 1. Nephrology and Dialysis Unit, SM Annunziata Hospital, ASL Toscana Centro, via dell'Antella, 50012, Firenze, Italy. fpizzarelli@yahoo.com. 2. Nephrology and Kidney Transplantation Unit, Department of Translational Medicine, University of Piemonte Orientale (UPO), Novara, Italy. 3. Nephrology and Dialysis Unit, Versilia Hospital, ASL Nord-Ovest, Lido Di Camaiore, Italy. 4. Nephrology and Dialysis Unit, SM Annunziata Hospital, ASL Toscana Centro, via dell'Antella, 50012, Firenze, Italy. 5. Lab Physiology, Department Translational Medicine, University of Piemonte Orientale (UPO), Novara, Italy. 6. Nephrology and Dialysis Unit, ASL Toscana Centro, Pistoia, Italy. 7. Nephrology and Dialysis Unit, NSGD Hospital, ASL Toscana Centro, Firenze, Italy. 8. Nephrology and Dialysis Unit, ASL Nord-Ovest, Massa Carrara, Italy. 9. Nephrology and Dialysis Unit, ASL VCO, Verbania, Verbano Cusio Ossola, Italy. 10. Nephrology and Dialysis Unit, Borgomanero Hospital, ASL NO Novara, Borgomanero, Italy. 11. Nephrology and Dialysis Unit, ASL Biella, Biella, Italy. 12. Nephrology and Dialysis Unit, ASL Vercelli, Vercelli, Italy. 13. Nephrology and Dialysis Unit, ASL Toscana Centro, Empoli, Italy.
Abstract
BACKGROUND: Studies addressing the anti-inflammatory properties of citrate dialysateenrolled patients in both hemodialysis (HD) and hemodiafiltration (HDF), the latter not adjusted for adequate convective exchange. This is a potential source of confounding in that HDF itself has anti-inflammatory effects regardless of the buffer, and optimal clinical outcomes are related to the amount of convection. METHODS: To distinguish the merits of the buffer from those of convection, we performed a 6-month, prospective, randomized, crossover AB-BA study. Comparisons were made during the 3-month study period of on-line HDF with standard dialysate containing three mmol of acetic acid (OL-HDFst) and the 3-month of OL-HDF with dialysate containing one mmol of citric acid (OL-HDFcit). Primary outcome measure of the study was interleukin-6 (IL-6). Klotho, high sensitivity C-reactive protein (hsCRP), fetuin and routine biochemical parameters were also analyzed. RESULTS: We analyzed 47 patients (mean age 64 years, range 27-84 years) enrolled in 10 participating Nephrology Units. Convective volumes were around 25 L/session with 90 percent of sessions > 20 L and ß2-microglobulin reduction rate 76% in both HDFs. Baseline median IL-6 values in OL-HDFst were 5.6 pg/ml (25:75 interquartile range IQR 2.9:10.6) and in OL-HDFcit 6.6 pg/ml (IQR 3.4:11.4 pg/ml). The difference was not statistically significant (p 0.88). IL-6 values were lower during OL-HDFcit than during OL-HDFst, both when analyzed as the median difference of overall IL-6 values (p 0.02) and as the median of pairwise differences between the baseline and the 3-month time points (p 0.03). The overall hsCRP values too, were lower during OL-HDFcit than during OL-HDFst (p 0.01). Klotho levels showed a time effect (p 0.02) and the increase was significant only during OL-HDFcit (p 0.01). CONCLUSIONS: Citrate buffer modulated IL-6, hsCRP and Klotho levels during high volume OL-HDF. These results are not attributable to differences in the dialysis schedule and may suggest a potential anti-inflammatory and anti-senescent effect of citrate even in dialysis patients with low grade inflammation. ClinicalTrials.gov identifier NCT02863016.
RCT Entities:
BACKGROUND: Studies addressing the anti-inflammatory properties of citrate dialysate enrolled patients in both hemodialysis (HD) and hemodiafiltration (HDF), the latter not adjusted for adequate convective exchange. This is a potential source of confounding in that HDF itself has anti-inflammatory effects regardless of the buffer, and optimal clinical outcomes are related to the amount of convection. METHODS: To distinguish the merits of the buffer from those of convection, we performed a 6-month, prospective, randomized, crossover AB-BA study. Comparisons were made during the 3-month study period of on-line HDF with standard dialysate containing three mmol of acetic acid (OL-HDFst) and the 3-month of OL-HDF with dialysate containing one mmol of citric acid (OL-HDFcit). Primary outcome measure of the study was interleukin-6 (IL-6). Klotho, high sensitivity C-reactive protein (hsCRP), fetuin and routine biochemical parameters were also analyzed. RESULTS: We analyzed 47 patients (mean age 64 years, range 27-84 years) enrolled in 10 participating Nephrology Units. Convective volumes were around 25 L/session with 90 percent of sessions > 20 L and ß2-microglobulin reduction rate 76% in both HDFs. Baseline median IL-6 values in OL-HDFst were 5.6 pg/ml (25:75 interquartile range IQR 2.9:10.6) and in OL-HDFcit 6.6 pg/ml (IQR 3.4:11.4 pg/ml). The difference was not statistically significant (p 0.88). IL-6 values were lower during OL-HDFcit than during OL-HDFst, both when analyzed as the median difference of overall IL-6 values (p 0.02) and as the median of pairwise differences between the baseline and the 3-month time points (p 0.03). The overall hsCRP values too, were lower during OL-HDFcit than during OL-HDFst (p 0.01). Klotho levels showed a time effect (p 0.02) and the increase was significant only during OL-HDFcit (p 0.01). CONCLUSIONS:Citrate buffer modulated IL-6, hsCRP and Klotho levels during high volume OL-HDF. These results are not attributable to differences in the dialysis schedule and may suggest a potential anti-inflammatory and anti-senescent effect of citrate even in dialysis patients with low grade inflammation. ClinicalTrials.gov identifier NCT02863016.
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