| 초록 |
Objectives: High dialysate calcium concentration is believed to be able to improve left ventricular ejection fraction (LVEF). To test the hypothesis that low dialysate calcium is not inferior to high dialysate calcium, with the use of a margin of 5% for the changes of LVEF during HD with low dialysate calcium as compared to high dialysate calcium.
Methods: A randomized, double-blinded, non-inferiority study was conducted. ESRD patients undergoing chronic HD were randomized into 2 groups: high dialysate calcium (1.75 mmol/L, Ca-1.75 group) and low dialysate calcium (1.25 mmol/L, Ca-1.25 group). The primary endpoint was the changes of LVEF, comparing between predialysis and 3-4 hours after dialysis. The secondary endpoints were episodes of intradialytic hypotension (IDH) and changes of c-reactive protein (CRP) and fibroblast growth factor-23 (FGF-23) during 6-month period.
Results: Seventy-eight ESRD patients were included (38 in Ca-1.25 group and 40 in Ca-1.75 group). Mean changes of LVEF during dialysis in Ca-1.25 group was +4.2 ± 6.8% vs +2.3 ± 6.5% in Ca-1.75 group (difference +1.9 ± 1.5, 95% CI -1.1 to +5.0, p=0.211). Mean changes of systolic blood pressure in Ca-1.25 group were -3.2 ± 20.5 mmHg vs +7.2 ± 17.6 mmHg in Ca-1.75 group (p=0.019). Episodes of IDH were higher in Ca-1.25 group, 337 from 2,723 dialysis sessions (12.4%) vs 205 from 3,031 dialysis sessions (6.8%) in Ca-1.75 group (p <0.001). Compared to Ca-1.75 group, CRP reduction was higher in Ca-1.25 group (p=0.036), however, changes of FGF-23 levels were not different between groups (p=0.464).
Conclusions: Improvement of LVEF during HD with dialysate calcium of 1.25 mmol/L was not inferior to those with dialysate calcium of 1.75 mmol/L. Although IDH was lower in Ca-1.75 group, CRP levels were significantly increased whilst changes of FGF levels were not different between groups.
(Clinical trial number: TCTR20170623001)
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