OBJECTIVE: We explored the safety and feasibility of PBD in hyperkalemic CKD patients receiving the potassium binder sodium zirconium cyclosilicate (SZC).
METHODS: In the current 6-wk trial, 26 hyperkalemic patients with CKD stage 4-5 not on dialysis received a low-protein low-potassium diet plus SZC for 3 wk and then a PBD with high potassium content delivered as a weekly food basket while continuing SZC for subsequent 3 wk. Plasma potassium was monitored weekly and SZC was titrated to achieve normokalemia. The 24-h urine excretion of potassium and sodium, 24-h food records, dietary quality, nutritional status, Bristol stool scale, Quality of life (QoL), and renal treatment satisfaction were assessed at baseline (week 0), week 3, and week 6.
RESULTS: Mean plasma potassium decreased from 5.5 to 4.4 mEq/L within 48-72 h after baseline, then rose to 4.7-5.0 mEq/L throughout the remaining study period following dose adjustments of SZC that matched the increased potassium intake of PBD from week 3 to week 6. Over the study period, 24-h urinary potassium excretion decreased from week 0 to week 3 and increased from week 3 to week 6. During the study, 58% of patients had fasting plasma potassium between 3.5 and 5.0 mEq/L and there was no episode of plasma potassium >6.5 mEq/L or <3.0 mEq/L during the study. P-carbon dioxide increased from baseline until week 6 (21 ± 2 to 23 ± 2 mEq/L; P = 0.002; mean ± SD), whereas remaining laboratory values remained unchanged. Fiber intake, dietary quality, the domain physical functioning from QoL, and 1 question of renal treatment satisfaction improved, whereas stool type and frequency did not change after starting PBD.
CONCLUSIONS: PBD in hyperkalemia-prone CKD patients receiving SZC improved dietary quality and increased the intake of healthy foods, whereas plasma potassium concentration remained stable within normal values for most patients.
BACKGROUND: This trial was registered at the https://clinicaltrials.gov/study/NCT04207203 as NCT04207203.
目的:我们探讨了PBD在接受钾结合剂环硅酸钠锆(SZC)的高钾血症CKD患者中的安全性和可行性。
方法:在目前为期6周的试验中,26例未接受透析的CKD4-5期高钾血症患者接受了低蛋白低钾饮食加SZC三周,然后将高钾含量的PBD作为每周食物篮递送,同时继续SZC持续三周。每周监测血浆钾,并滴定SZC以达到正常钾血症。24小时尿液排泄钾和钠,24小时食物记录,饮食质量,营养状况,布里斯托尔粪便垢,在基线(第0周)评估生活质量(QoL)和肾脏治疗满意度,第3周和第6周。
结果:基线后48-72小时内平均血浆钾从5.5下降到4.4mEq/L,然后在整个剩余研究期间,在SZC的剂量调整后,从第3周到第6周与PBD的钾摄入量增加相匹配,升至4.7-5.0mEq/L。24小时尿钾排泄从第0周到第3周减少,从第3周到第6周增加。58%的患者空腹血浆钾在3.5至5.0mEq/L之间,并且在研究期间没有血浆钾>6.5mEq/L或<3.0mEq/L的发作。P-二氧化碳从基线增加直到第6周(21±2至23±2mEq/L;p=0.002;平均值±标准偏差),而其余实验室值保持不变。纤维摄入量,饮食质量,开始PBD后,来自QoL的领域身体功能和肾脏治疗满意度的一个问题得到了改善,而粪便类型和频率没有变化。
结论:在高钾血症易发CKD患者中,接受SZC的PBD改善了饮食质量并增加了健康食品的摄入量,而大多数患者的血浆钾浓度稳定在正常值内。临床试验登记号NCT04207203(https://clinicaltrials.gov/study/NCT04207203)。