Rationale & Objective

Hypervolemia and vitamin D deficiency occur frequently in patients receiving peritoneal dialysis and may contribute to left ventricular (LV) hypertrophy. The effect of bioelectrical impedance analysis (BIA)-guided volume management or vitamin D supplementation on LV mass among those receiving peritoneal dialysis is uncertain.

Study Design

Two-by-two factorial randomized controlled trial.

Setting & Participants

Sixty-five patients receiving maintenance peritoneal dialysis.

Intervention

BIA-guided volume management versus usual care and oral cholecalciferol 50,000 U weekly for 8 weeks followed by 10,000 U weekly for 44 weeks or matching placebo.

Outcome

Change in LV mass at 1 year measured by cardiac magnetic resonance imaging.

Results

Total body water decreased by 0.9 + 2.4 (SD) L in the BIA group compared with a 1.5 ± 3.4 L increase in the usual care group (adjusted between-group difference: −2.4 [95% CI, −4.1 to −0.68] L, P = 0.01). LV mass increased by 1.3 ± 14.3 g in the BIA group and decreased by 2.4 ± 37.7 g in the usual care group (between-group difference: +2.2 [95% CI, −13.9 to 18.3] g, P = 0.8). Serum 25-hydroxyvitamin D concentration increased by a mean of 17.2 ± 30.8 nmol/L in the cholecalciferol group and declined by 8.2 ± 24.3 nmol/L in the placebo group (between-group difference: 28.3 [95% CI, 17.2-39.4] nmol/L, P < 0.001). LV mass decreased by 3.0 ± 28.1 g in the cholecalciferol group and increased by 2.0 ± 31.2 g in the placebo group (between-group difference: −4.5 [95% CI, −20.4 to 11.5] g, P = 0.6).

Limitations

Relatively small sample size with larger than expected variation in change in LV mass.

Conclusions

BIA-guided volume management had a modest impact on volume status with no effect on the change in LV mass. Vitamin D supplementation increased serum vitamin D concentration but had no effect on LV mass.

Funding

Unrestricted Baxter International extramural grant and the Kidney Foundation of Canada.

Trial Registration

Registered at ClinicalTrials.gov with study number NCT01045980.

中文翻译：

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生物电阻抗引导的液体管理和补充维生素 D 对接受腹膜透析的患者左心室肿块的影响：一项随机对照试验

基本原理和目标

接受腹膜透析的患者经常出现血容量过多和维生素 D 缺乏，并可能导致左心室 (LV) 肥大。在接受腹膜透析的患者中，生物电阻抗分析 (BIA) 指导的容量管理或补充维生素 D 对 LV 质量的影响尚不确定。

学习规划

2×2 因子随机对照试验。

设置与参与者

65 名患者接受维持性腹膜透析。

干涉

BIA 指导的容量管理与常规护理和口服胆钙化醇 50,000 U 每周持续 8 周，然后每周 10,000 U 持续 44 周或匹配安慰剂。

结果

通过心脏磁共振成像测量 1 年时 LV 质量的变化。

结果

BIA 组的总体水减少了 0.9 + 2.4 (SD) L，而常规护理组增加了 1.5 ± 3.4 L（调整后的组间差异：-2.4 [95% CI，-4.1 至 -0.68] L , P  = 0.01)。BIA 组 LV 质量增加 1.3 ± 14.3 g，常规护理组减少 2.4 ± 37.7 g（组间差异：+2.2 [95% CI，-13.9 至 18.3] g，P  = 0.8）。胆钙化醇组血清 25-羟基维生素 D 浓度平均增加 17.2 ± 30.8 nmol/L，安慰剂组下降 8.2 ± 24.3 nmol/L（组间差异：28.3 [95% CI，17.2-39.4] nmol/L, P < 0.001)。胆钙化醇组 LV 质量减少 3.0 ± 28.1 g，安慰剂组增加 2.0 ± 31.2 g（组间差异：-4.5 [95% CI，-20.4 至 11.5] g，P  = 0.6）。

限制

相对较小的样本量，LV 质量变化的变化大于预期。

结论

BIA 指导的容量管理对容量状态的影响不大，但对 LV 质量的变化没有影响。补充维生素 D 可增加血清维生素 D 浓度，但对 LV 质量没有影响。

资金

不受限制的百特国际校外资助和加拿大肾脏基金会。

试用注册

在 ClinicalTrials.gov 注册，研究编号为 NCT01045980。