METHODS: A double-blind randomized study was conducted. Patients were randomized into two groups: bumetanide plus chlorthalidone group (intervention) and the bumetanide plus placebo group (control) to evaluate differences in TBW, ECW and ECW/TBW between baseline and 30 Days of follow-up. Volume overload was defined as \'bioelectrical impedance analysis as fluid volume above the 90th percentile of a presumed healthy reference population. The study\'s registration number was NCT03923933.
RESULTS: Thirty-two patients with a mean age of 57.2 ± 9.34 years and a median estimated glomerular filtration rate (eGFR) of 16.7 ml/min/1.73 m2 (2.2-29) were included. There was decreased volume overload in the liters of total body water (TBW) on Day 7 (intervention: -2.5 vs. control: -0.59, p = 0.003) and Day 30 (intervention: -5.3 vs. control: -0.07, p = 0.016); and in liters of extracellular water (ECW) on Day 7 (intervention: -1.58 vs. control: -0.43, p < 0.001) and Day 30 (intervention: -3.05 vs. control: -0.15, p < 0.000). There was also a decrease in systolic blood pressure on Day 7 (intervention: -18 vs. control: -7.5, p = 0.073) and Day 30 (intervention: -26.1 vs. control: -10, p = 0.028) and in diastolic blood pressure on Day 7 (intervention: -8.5 vs. control: -2.25, p = 0.059) and Day 30 (intervention: -13.5 vs. control: -3.4, p = 0.018).
CONCLUSIONS: In CKD stage 4-5 KDIGO without renal replacement therapy, bumetanide in combination with chlorthalidone is more effective in treating volume overload and hypertension than bumetanide with placebo.
方法:进行双盲随机研究。患者被随机分为两组:布美他尼加氯噻酮组(干预)和布美他尼加安慰剂组(对照组),以评估TBW的差异。基线和随访30天之间的ECW和ECW/TBW。体积超负荷定义为生物电阻抗分析,即假定健康参考人群的第90百分位数以上的液体体积。该研究的注册号为NCT03923933。
结果:纳入32例患者,平均年龄为57.2±9.34岁,肾小球滤过率(eGFR)中位数为16.7ml/min/1.73m2(2.2-29)。第7天全身水(TBW)的升容量超负荷减少(干预:-2.5vs.对照:-0.59,p=0.003)和第30天(干预:-5.3vs.对照:-0.07,p=0.016);第7天的细胞外水(ECW)升数(干预:-1.58vs.对照:-0.43,p<0.001)和第30天(干预:-3.05vs.控制:-0.15,p<0.000)。第7天收缩压也降低(干预:-18vs.控制:-7.5,p=0.073)和第30天(干预:-26.1vs.控制:-10,p=0.028)和第7天的舒张压(干预:-8.5vs.控制:-2.25,p=0.059)和第30天(干预:-13.5vs.控制:-3.4,p=0.018)。
结论:在没有肾脏替代治疗的CKD4-5期KDIGO中,布美他尼与氯噻酮联合治疗容量超负荷和高血压比安慰剂更有效。